cyrilzakka/clinical-trials huggingface dataset:
Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis

To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry eye.

It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the stinging with cyclosporine administration and the dry eye signs and symptoms experienced during the initiation of therapy.

Dry eye is an ocular surface disease that produces discomfort and irritation. Estimated prevalence ranges from 20 million people in the US being affected with mild to moderate dry eye, to as many as one out of every five Americans.

A growing body of evidence has associated ocular inflammation with the signs and symptoms of dry eye.

Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with a condition called keratoconjunctivitis sicca. The relief of dry eye signs and symptoms with Restasis therapy is often delayed by 1 to 6 months from the initiation of therapy. Stinging on installation, particularly when initiating therapy, has been reported.

Lotemax, an ophthalmic corticosteroid, targets inflammation with a unique, site-active mechanism of action.Structural modifications associated with an ester ophthalmic steroid make Lotemax highly lipid soluble, enhancing penetration into cells and enabling Lotemax to exert anti-inflammatory activity within the eye. Lotemax is indicated for the treatment of steroid responsive inflammatory conditions associated with the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 30 and 80 inclusive.
* Has not worn contact lenses for at least 1 month prior to the study and agrees to not wear contact lenses during study.
* Oral medications stable 1 month prior to study.
* Oral medications anticipated to be stable during 60 day study.
* Patient is in generally good \& stable overall health.
* Patient likely to comply with eye drop regimen, study guidelines \& study visits.
* Corneal stain \> 1+ or Conjunctival stain \> 1+ or OSDI equal or \> 5 or using regular artificial tears at least on average twice daily.
* Informed consent signed.

Exclusion Criteria:

* History of Stevens-Johnson Syndrome or Ocular Pemphigoid.
* Punctal plugs inserted or punctal cautery in the past 3 months.
* Intra-ocular surgery within 6 months or ocular laser surgery within 3 months.
* History of liver disease.
* Pregnant or lactating women.
* Severe clinical vitamin deficiencies or history of vitamin overdose.
* Highly variable vitamin intake.
* Unstable use of systemic or topical medications known to create dry eye.
* Corneal pathology, which could, of itself, cause an ocular surface disorder.
* Use of glaucoma medications, topical or oral.
* Unstable diabetes mellitus.
* Allergy or sensitivity to Lotemax, Restasis or the OTC Tear Supplement.
* Use of topical steroids or Restasis within the past 1 month.
* Use of other topical ocular agents other than tear replacements within the past 1 week.
A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)

This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75
* Performance status 0 or 1 (ECOG)
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3
* Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ ULN
* Renal Creatinine ≤ ULN

Exclusion Criteria:

* Prior anticancer treatment
Improving Employment in Patients Who Have Survived Cervical Cancer, Uterine Cancer, or Ovarian Cancer

RATIONALE: Finding out which problems affect employment in survivors of gynecologic cancer may help in planning cancer treatment and improve the quality of life of future cancer survivors.

PURPOSE: This research study is looking at ways to improve employment in patients who have survived cervical cancer, uterine cancer, or ovarian cancer.

OBJECTIVES:

* Conduct formative work, including 4 to 5 focus groups, leading to development of a structured interview instrument assessing factors related to employment outcomes among women with gynecologic cancers.
* Pilot a recruitment strategy and administer the interview among a sample of 60 to 70 gynecologic cancer survivors; and, with each woman's permission, a family member, a key health care provider, and her supervisor will be interviewed.

OUTLINE: This is a multicenter, pilot study.

Patients complete a survey, meet with a focus group, and undergo a short interview. Patient-designated participants are also interviewed; these individuals may include a health care provider, a significant other, and/or a work supervisor.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following invasive cancers:

  * Cervical cancer
  * Uterine cancer
  * Ovarian cancer
* Diagnosed ≥ 6 months ago
* Any stage disease
* Employed at the time of diagnosis, defined as working for pay ≥ 20 hours/week

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
The Effect of Reducing Soreness in Marathon Runners

Delayed onset muscle soreness is defined as the sensition of pain and discomfort in skeletal muscles that occurs after eccentric muscle actions or strenuous exercise like a marathon.

There is a growing body of clinical evidence which shows that noninvasive, nonpharmacologic pulsed electromagnetic fields have many clinical effects. Pulsed electromagnetic fields have shown to reduce pain in different groups of patients. This concerns patients with osteoarthritis, rheumatoid arthritis, diabetic neuropathy, fibromyalgia, distal radius fractures, pelvic pain and postoperative patients.

A marathon is a muscular strain. Physiologic effects of a marathon involves muscular and connective tissue damage which initiates an inflammatory response as well as release of metabolic factors like lactate and free radicals, intracellular metabolites and by-products of proteolysis.

The objective of this study was to investigate the efficacy of pulsed electromagnetic fields compared to placebo in reducing delayed onset muscle soreness in marathon runners.

Eligibility Criteria:
Inclusion Criteria:

* Completion of a marathon
* Age \> 18 years

Exclusion Criteria:

- Unable to read and speak Danish
Bionenergetic Balance During CVVH

The bioenergetic balance is the sum of energy exchanged during CRRT and is mostly defined by citrate glucose and lactate. When CRRT was performed with the older dialysis fluids, glucose and lactate could be an important source of energy next to citrate when used as predilution (6, 7). During continuous venovenous hemofiltration (CVVH), a subgroup of CRRT which is performed with the newer dialysis fluids without lactate or glucose as advocated by the KDIGOguidelines, glucose and in a minor way lactate mostly induce a loss of energy. The first aim is to determine how this bioenergetic balance impacts energy need compared to the measured energy with indirect calorimetry and how nutrition therapy needs to be adapted.

Also, disease specific predicting equation have been created for patients suffering from acute kidney injury treated with renal replacement therapy. How this predicting equation and other existing predicting equations agree with the measured REE has not been validated yet. The second aim is to determine how predictive equations correlate with measured REE in patients treated with CVVH.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the adult ICU (01/01/2021-30/09/2022)
* At least one indirect calorimetry measurement (ventilator) or calculation based on harris benedict OR 25Kcal/kg/day
* Combined with bio energetic balance measurement
* Receiving CVVH during intensive care stay

Exclusion Criteria:

* Patients admitted outside of the inclusion period will be excluded
* The absence of an indirect calorimetry measurement (ventilator) or calculation - based on the Harris Benedict OR 25Kcal/kg/day formula OR The absence of a bio energetic balance measurement
* The absence of CVVH during intensive care stay
* Pediatric (intensive care unit) patients
Magnification Narrow Band Imaging Colonoscopy for Hereditary Non-Polyposis Colorectal Cancer Surveillance

The purpose of this study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI)can help doctors detect more patients with at least one pre-cancerous area than conventional colonoscopy using white light alone in patients with genetically inherited high risk for bowel cancer (HNPCC).

Colorectal cancer is the second commonest cause of cancer death. Some people have an inherited defect in the genes which repair DNA which results in a very high risk of colorectal (bowel) cancer at a young age. This syndrome is called hereditary non-polyposis colorectal cancer (HNPCC) or Lynch syndrome. Colonoscopic surveillance of HNPCC patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed.

Precancerous lesions in HNPCC are difficult to see and may be advanced even if as small as a few millimeters. Endoscopists have used spraying dye on the lining of bowel (Chromoendoscopy) successfully to improve detection of abnormal areas; however this is time consuming and requires extra time and equipment and despite the benefits seen in two studies is not widely used in routine clinical practice in the UK.

Narrow Band Imaging (NBI) is a technique that relies on light to improve contrast for the smallest blood vessels in the bowel lining which shows up precancerous areas as they have a richer vascular network. It is sometimes described as "digital chromoendoscopy" as the images produced are similar to chromoendoscopy, but it is much simpler and quicker to use. With magnification it allows assessment of the fine mucosal surace pattern (pit pattern) of lesion which allows an assessment of their likelihood of being precancerous. Autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out. These techniques have been used with some success in the oesophagus and stomach but little work is available for the colon.

We aim to see if NBI with magnification is better than standard colonoscopy for detecting precancerous areas. This is likely as it produces images similar to chromoendoscopy which is already shown to help. If a potentially precancerous area is found we will use other types of endoscopy, in particular NBI and autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non-cancerous areas.

Eligibility Criteria:
Inclusion Criteria:

* patients with HNPCC according to the Amsterdam II criteria
* patients over 18 years

Exclusion Criteria:

* pregnant patients
* unable or unwilling to give consent
Tofacitinib for the Treatment of Alopecia Areata and Its Variants

The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old
* Diagnosis of alopecia areata with \>50% scalp involvement, alopecia totalis, or alopecia universalis
* Hair loss present for at least 6 months
* No treatment for alopecia areata in past 2 months
* No evidence of hair regrowth
* Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication
* Fluent in spoken and written English

Exclusion Criteria:

* Age \<18 years old
* Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
* Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
* Patients known to be HIV or hepatitis B or C positive
* Patients with positive tuberculin skin test or positive QuantiFERON TB test
* Patients with leukopenia or anemia
* Patients with renal or hepatic impairment
* Patients with peptic ulcer disease
* Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
* Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
* Women who are pregnant or nursing
Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

The purpose of the study is to test whether atorvastatin (also known as Lipitor) has anti-inflammatory effects in people with no known heart disease or high cholesterol. We also are investigating whether or not genetic differences between people plays a role in the drug response.

All subjects received 16 weeks of Atorvastatin after a two week run in. Key dependent variables were the 16 week value minus the baseline value (post run-in). Last observation carried forward was used for missing values. The key comparisons are for two groups OATP1B1 reduced carriers and on-carriers and their association with Cytokines and Lipids. Secondarily, we were interested in changes over the 16 weeks for the pooled sample, irrespective of genetics.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years old
* Normocholesterolemic

Exclusion Criteria:

* Cardiovascular disease or risk equivalents
* Malignancy
* Active alcohol abuse
* Contraindications to statins
* Interacting drugs
* Chronic anti-inflammatory drugs
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer

This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer

In this pilot phase II study, the investigators enrolled Chinese adults(age 18 to 70 years) with locally advanced stage II/III rectal cancer. The neuadjuvant chemotherapy regimen is : oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with 5FU 2,400 mg/m2 by 46 h infusion, repeated at 2week intervals for 5 cycles. Total mesorectal excision was scheduled 4-5 weeks after completion of neoadjuvant treatment and followed by a further 7 cycles of mFOLFOX or 4 cycles of XELOX. Primary outcome measures of this phase II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed locally advanced rectal cancer;
2. 18-70 years ；
3. Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0;
4. Tumor from anus \>5cm and ≤15cm;
5. ECOG=0-1;
6. Available organ function:ALT≤1.5xULN;AST≤1.5xULN;TBIL≤1.0xULN; NEUT≥2×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;
7. Informed consent;
8. UGT1A1:UGT1A1\*1/UGT1A1\*1,UGT1A1\*1/UGT1A1\*28,UGT1A1\*1/UGT1A1\*6;

Exclusion Criteria:

1. Clinical stage T4b or unresectable disease;
2. History of pelvic radiotherapy;
3. History of chemotherapy within 5 years;
4. History of chronic diarrhea;
5. Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding;
6. Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause;
7. UGT1A1:UGT1A1\*28/UGT1A1\*28,UGT1A1\*6/UGT1A1\*6;
8. Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer;
9. Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency;
10. Mental illness;Pregnant or lactating women;
Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients After Pancreatic Procedures.

This study investigates the development of intra-abdominal hypertension and compartment syndrome in patients undergoing elective pancreatic procedures. Main objective is to determine the proportion of patients after pancreatic operation who develop elevated intra-abdominal pressure and assess its association with postoperative complication rates. Another goal of the study is to compare open versus robotic pancreatic procedures regarding the occurrence of intra-abdominal hypertension and abdominal compartment syndrome.

HYPA study is designed as a prospective observational study. The primary objective of this study is to assess the risk and prevalence of intra-abdominal hypertension and abdominal compartment syndrome following pancreatic procedures. The secondary objective aims to explore potential correlations between intra-abdominal hypertension and the development of postoperative complications, such as anastomotic dehiscence, postoperative pancreatic fistulas, prolonged postoperative ileus, or delayed gastric emptying. The third objective is to compare the incidence of intra-abdominal hypertension in patients undergoing robotic versus open pancreatic procedures

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18-year-old
* Indication for elective pancreatic procedure
* Written informed consent

Exclusion Criteria:

* Patients \<18 years old.
* Contraindication for urinary catheter placement.
* Refusal to participate in the study.
Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

The study had two objectives. The first main aim was to analyze the effects of tryptophan and magnesium-enriched Mediterranean diet on psychological variables (trait anxiety, self-image, mood state, eating disorders) and sleep effects in women with fibromyalgia. Our hypothesis, based on previous positive effects of tryptophan and magnesium supplementation by separate in this population, may improve psychological health and regulate sleep disruptions. The second aim was to assess the effectiveness of a manual therapy technique performed with moderate digital pressure in fibromyalgia patients on the variables of fatigue, pain, sleep, anxiety and mood. It was done to provide an alternative treatment to pharmacological therapies for fibromyalgia patients and to provide new evidence on the effects of manual therapy in fibromyalgia patients.


Eligibility Criteria:
Inclusion Criteria:

- Women aged 40-60 with fibromialgia (officially diagnosed).

Exclusion Criteria:

* Women used analgesics, vitamins containing supplements, and or other drugs for the treatment of fibromyalgia symptoms, or participation in other clinical trials.
* Women that be performing simultaneously to this study some other physical therapy or physical exercise treatment. Not having sufficient cognitive level to collaborate in the study or not having the possibility of attending the established sessions.
Growth Factors and Hepatic Progenitor Cells in Acute Liver Failure

To study the correlation of serological growth factors and the hepatic progenitor cells involved in liver regeneration of liver failure.


Eligibility Criteria:
Inclusion Criteria:

Acute liver failure Received iver transplantation

Exclusion Criteria:

Pregnancy Sepsis Heart failure
Fiber Fermentation Study

The aim of the study is to better understand the interplay between the intake of dietary fiber and intestinal bacteria, their metabolic activity and the effect on the intestinal barrier.

The effect of two different dietary fiber supplements is tested (arabinoxylan \& ß-glucan versus inulin \& fructooligosaccharides) in a randomized crossover intervention trial including healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years
* signed written informed consent
* willingness not to change the dietary pattern in the course of the study

Exclusion Criteria:

* BMI below 18 or above 30
* acute or chronic gastrointestinal symptoms
* neoplastic diseases
* very strict diets, including raw foodists and frutarians
* regular smoking (more than one box per day)
* intake of antibiotics, immunosuppressants, or any intestinal therapeutics three months prior to study begin
* supplementation of fibers three months prior to study begin
* simultaneous participation in another clinical study
* pregnancy / breastfeeding
* relevant violations of the study protocol
* intolerance to the fiber supplements (including wheat, oat, chicory)
* occurrence of relevant diseases (individual decision by study physicians)
* revocation of consent
* placement in a clinic or similar facility based on an official or court order
The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO)

The purpose of this study is to understand more about meeting the psychosocial needs of people who have cancer.

The investigators are interested in the feasibility of using computer assisted screening and assessment to meet the psychosocial needs of people with cancer. The investigators are studying two different interventions. Both groups will receive health information, referral information, and resources. One group will also receive tailored feedback reports.

Eligibility Criteria:
Inclusion Criteria:

* cancer diagnosis
A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer

This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions.

This was a Phase 2a, two-staged, single-arm, open-label study in sorafenib-naïve patients with advanced HCC.

Patients received 5 weekly IV infusions of Pexa-Vec and could have continued to receive IV infusions of Pexa-Vec every 3 weeks until progressive disease (PD).

Eligibility Criteria:
KEY Inclusion Criteria:

* Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma (HCC)
* Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the arterial phase on CT scanning)
* ECOG performance status 0, 1 or 2
* Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
* Platelet count ≥50,000 plts/mm3
* WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3
* Hemoglobin ≥10 g/dL
* Adequate liver function

KEY Exclusion Criteria:

* Received sorafenib as previous treatment for HCC for more than 14 days
* History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis requiring systemic therapy for \> 4 weeks)
* Prior treatment with JX-594
* Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
* Severe or unstable cardiac disease
* Viable CNS malignancy associated with clinical symptoms
* Pregnant or nursing an infant
* Significant bleeding event within the last 12 months.