cyrilzakka/clinical-trials huggingface dataset:
Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders

The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. In this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.

The purpose of the study is to determine if neo-adjuvant FOLFOX therapy and lengthening the time interval between neo-adjuvant chemotherapy and transanal local excision will increase the percentage of patients with pathologic complete remission.

This is a prospective pilot study to examine the impact of two variables: 1) addition of neo-adjuvant FOLFOX chemotherapy, and 2) increasing the time interval between completion of chemo-radiotherapy and subsequent surgery, on the rate of achieving pathologic complete remission with avoidance of radical resection while maintaining an excellent local control with improvement of quality of life.

All procedures in this study are standard of care, the study question relates to the use of neo-adjuvant FOLFOX and the timing between the end of radiation and surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosis of rectal invasive adenocarcinoma
3. Tumor in the low or mid rectum (up to 11 cm from the anal verge)
4. Clinical stage T3/N0-N1M0. Patients with low T2 who will need abdominal perineal resection are also eligible.

1. Clinical staging will be estimated based on the combination of the following assessments:

1. Physical examination by the primary surgeon
2. Computed Tomography or Positron Emission Tomography/Computed Tomography scan of chest, abdomen and pelvis
3. Pelvic MRI and endoscopic ultrasound

Exclusion Criteria:

* Less than 18 years of age
* Do not complete informed consent
* Pregnant women
KM110329 in Adult Patients With Atopic Dermatitis

The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic dermatitis.

A randomized, double blind, placebo-controlled, multicenter trial will be conducted at the Seoul St.Mary's Hospital, at Chung-ang University hospital, and at Kyung Hee University Hospital at Gangdong.

Participants fulfilling eligibility criteria will be selected. Enrolled participants will be randomly allocated to two parallel groups: the KM110329 and placebo arms.

Each participant will be examined for signs and symptoms of Atopic dermatitis before and after taking functional food.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 to 65 years
* Individuals who diagnosed Atopic dermatitis according to the criteria of Hanifin and Rajka
* Individuals who mild to moderate atopic dermatitis (objective SCORAD≤40)
* Written informed consent for participation in the trial

Exclusion Criteria:

* Severe skin disease other than Atopic dermatitis
* Secondary infection with bacteria, fungi, and virus
* Uncontrolled hypertension (SBP \> 145 mmHg or DBP \> 95 mmHg)
* Severe liver disability (2.5-fold the normal high range value for ALT, AST)
* Severe renal disability (sCr \> 2.0mg/dl)
* Women who are pregnant, lactating, planning a pregnancy or women of child-bearing age who do not agree to proper contraception
* Use of oral steroids, oral antibiotic or other immunosuppressants within the past 4 weeks
* Treated by systemic photochemotherapy within past 4 weeks
* History of drug abuse
* Hypersensitivity to Rubi Fructus, Houttuyniae Herba, Rehmanniae Radix, Betulae Platyphyllae Cortex
* Use of other investigational products within the past two months
Skeletal Muscle Myokine Response to Acute Eccentric Exercise

The purpose of this study is to evaluate the acute local skeletal muscle inflammatory response to thigh muscle (quadriceps) eccentric muscle actions. Eccentric muscle actions occur when the muscle is lengthening as it contracts. This is a pilot project to assess the degree of inflammatory biomarkers, called myokines, that are released locally in skeletal muscle tissue after an acute bout of resistance-exercise using a resistance-exercise machine called an isokinetic dynamometer.

The intervention will involve one session of maximal eccentric exercise of the knee extensor muscles (quadriceps) of the right leg. During the 24-hour period preceding the intervention, participants will be asked to refrain from any for of moderate-vigorous physical activity or exercise. Participants will perform 30 sets of 10 repetitions of maximal isokinetic eccentric knee extensions at 60 degrees/second with 1-minute of rest between each set. Before completing the exercise bout, each participant will be asked to remain in a seated position (resting) for 30-minutes and then provide a skeletal muscle biopsy using the modified Bergstrom with suction muscle biopsy technique from the vastus lateralis on the right leg. This will be done for the baseline assessment of 5 myokines including apelin, fibroblast growth factor-21, irisin, interleukin-6, and interleukin-15. Then the participants will complete the exercise bout as described above. They will then rest quietly in the laboratory for 3-hours and wait for the second skeletal muscle biopsy to be taken following this 3-hour wait.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old
* healthy
* recreationally active (\>/= 150 minutes of moderate to vigorous physical activity per week for at least the past three months)

Exclusion Criteria:

* "yes" answer to the Get Active Questionnaire which screens for health conditions that may affect exercise ability
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis

The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.

The purpose of this study is to investigate the safety and possible usefulness of infliximab therapy for patients with severe plaque psoriasis. In a previous small study of infliximab in 33 patients with psoriasis, about 80% of patients treated with infliximab showed improvement in their psoriasis symptoms after the first 3 infusions, while 20% of patients who received placebo showed improvement. The patients will receive infusions of infliximab either 3 or 5 mg/kg or placebo at weeks 0,2,6. Patients who have significant psoriasis at week 26 will receive an additional infusion.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older at time of enrollment
* may be male or female
* Have had a diagnosis of plaque-type psoriasis at least 6 months prior to screening
* Have plaque-type psoriasis covering at least 10% of total BSA at baseline
* Have previously received PUVA and/or other systemic treatment for psoriasis

Exclusion Criteria:

* Have non-plaque forms of psoriasis
* Have a history of drug-induced psoriasis
* Are pregnant, nursing, or planning pregnancy within 12 months of enrollment
* Have had any previous treatment with infliximab or any therapeutic agent
Impact of HLA-E Overexpression by Tumor Cells on the Biology of TIL in Colorectal Cancer

Accumulating evidences suggest that colorectal cancer (CRC) progression is not solely determined by the genetic abnormalities of the tumor cells but also by the host response. Indeed, recent studies in CRC have associated improved survival with a high number of tumor-infiltrating (TIL) memory and cytotoxic T lymphocytes, suggesting a link between tumor progression and in situ T cell response. Gene expression profiling studies have clearly isolated a well-known subgroup of CRC characterized by microsatellite instability (MSI) CRC, associated with a strong immune response signature involving both Th1/cytotoxic and immune evasion pathways. Moreover, the investigators have previously shown that HLA-E/β2m is overexpressed by tumor cells in roughly 20% of CRC and is associated with a worse prognosis, most likely due to NK and T effector cell functions upon engagement with the inhibitory NK receptor CD94/NKG2A. However, our recent results on an enlarger cohort of patients suggest that if this observation holds true for MSS CRC, HLA-E over-expression is inversely associated with a good prognosis in MSI CRC. Thus, the phenotype and function of TIL, depending on the MSI/MSS status of CRC have to be precised. The investigators hypothesized that in MSI CRC, known to express a high number of MSI-H related frameshift peptides which represent a pool of tumor specific antigens, HLA-E could present peptides to TCR of non conventional CD8+ HLA-E-restricted alpha-betaT cells (also expressing CD94), then inducing a strong antitumor cytolytic activity. Therefore, the aim of this project is to determine the exact phenotype, function and specificity of the CD94+ TIL in CRC, depending on both the HLA-E and the MSI/MSS status of tumor cells. These results could impact the clinical practice as anti-NKG2A monoclonal antibodies or frameshift peptide based immunotherapy that could be promising new therapeutic options in CRC patients.


Eligibility Criteria:
Inclusion Criteria:

* Major patients treated surgically for colorectal cancer at the Nantes University Hospital or the West Institute of Cancerology
* Patients agreeing to participate in the study

Non inclusion Criteria:

* Age\> 85 years
* Neoadjuvant or immunosuppressive therapy for other pathology
* Size of the tumor insufficient to carry out all the samples dedicated to the research without constraining the diagnostic step (tumoral sampling at least equal to 1 cm3)
Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers

The hypothesis of the study is that the motility of the small intestine and the colon will alter according to the subtype of the irritable bowel syndrome (IBS) patient.

IBS is currently classified into following subtypes:

* Diarrhoea-IBS (IBS-D)
* Constipation-IBS (IBS-C)
* Mixed-IBS (IBS-M)
* Unsubtyped-IBS (IBS-U)

according to the Bristol scale.

Magnetic Tracking System (MTS) is a new minimal invasive technic that allows motility studies of the whole human gastrointestinal tract.

The magnetic cylindrical pill (6x15mm) is swallowed at 9 AM on day one. The recording is made until 4 PM and again from 8 AM until 2 PM on day two. The patient is placed in a bed and will be supplied with standardized food and fluid.

The Magnetic Tracking System consists of a 4 x 4 matrix of sensors positioned with respect to the anatomical reference points. Before measurements, the matrix is calibrated by offsetting the earth's and environmental magnetic fields. During the experiment, the magnet coordinates are continuously monitored and transmitted to a computer for processing and storage. Respiratory artifacts will be filtered out. Digestive movements will then be classified as 1) non-propulsive or 2) propulsive and transformed into either trajectory or dynamic graphs of the digestive motility.

The Magnetic Tracking System has the advantage from both radiographic and scintigraphic methods of conducting the tests without any radiation exposure to the patient. Preliminary studies have shown good concordance between the transit measured with the magnet and radiographic transit times.

The investigators wish to use this method, MTS, to compare the motility of the small intestine and the colon in patients with IBS-D and IBS-C as well as to compare these to groups to MTS done on healthy volunteers under the same conditions as the IBS patients.

A MTS study on healthy volunteers is all ready done under the same conditions as described abow in Denmark. This study has projectID 20080037 and is approved by the Danish Dataprotection Agency as well as The Regional Committee on Biomedical Research Ethics.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18.
* Patients who are diagnosed with IBS according to the Rome III criteria.
* A total symptom score in GSRS-IBS at a minimum of 40 points.
* Patients who are psychologically stable and suitable for observation and able to provide informed consent.

Exclusion Criteria:

* Overt bowel diseases including inflammatory bowel disease.
* Pregnant or breast feeding.
* Patients who are considered unable to follow the planned programme of the study, including mental illness or physiological instability.
* Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease.
Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

A Phase I, Multi-Centre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940, Including an Interaction Study, After Administration of Oral Multiple Ascending Doses in Adult Subjects with Chronic Low Back Pain


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Chronic Low Back Pain according to Quebec Task force Class 1-3 and an average pain intensity score of 3-9 on NRS(0-10) during the past week.
* Clinical normal physical findings, including blood pressure, pulse rate \> 45bpm, ECG (with normal QTcF interval \<450msec and without any additional risk factors for Torsades de Pointes) and laboratory assessments, as judged by investigator
* Body Mass Index (BMI) ≥18 to ≤32 kg/m2 inclusive and body weight ≥50 to ≤100 kg

Exclusion Criteria:

* History of somatic disease/condition which may interfere with the objectives of the study, with the exception of Chronic Low Back Pain
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder
* Clinically significant illness with the exception of Chronic Low Back Pain
Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests

This study plans to learn more about what patients think about screening for esophageal cancer (EAC) and Barrett's esophagus (BE); a pre-cancerous condition associated with esophageal cancer. The plan is to use this information to modify screening practices in the United States with the goal to decrease the number of people who die from esophageal cancer.

To achieve this goal, patient preferences for BE/EAC screening tests will be evaluated through a prospective multicenter discrete choice-based conjoint survey. Patients will choose between a series of hypothetical options and rank their priorities and what they value according to differences in benefit of detection (sensitivity), convenience (time, setting), screening related physical harms (procedural discomfort), and financial harms. By evaluating relative importance of test characteristics and patient prioritization the study will (1) define patient preferences and barriers for attributes of BE/EAC screening modalities to elicit the overall preferred test as well as differences in each attribute that informed that choice and (2) characterize differences in BE/EAC test preferences by patient sociodemographic characteristics (age, sex, race, ethnicity) and by the presence or absence of gastroesophageal reflux disease (GERD).

Eligibility Criteria:
Inclusion Criteria:

* Provision to sign and date the consent form.
* Stated willingness to comply with all study procedures and be available for the duration of the study.
* Individual has 3 or more established risk factors for BE (age \> 50 years, chronic GERD, male, white race, smoking, obesity, family history of BE/EAC).

Exclusion Criteria:

* Unable to consent.
* Prior diagnosis of BE/EAC.
* Life limiting comorbidity/ disability.
* Active dementia/ cognitive impairment.
* Incarcerated.
Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD

This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD


Eligibility Criteria:
Inclusion Criteria:

* Patients who have signed Informed Consent Form prior to initiation of any study-related procedure.
* Male and female adults aged ≥ 40 years.
* Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines.
* Patients with a post-bronchodilator FEV1 ≥40 and \< 80% of the predicted normal value, and post-bronchodilator FEV1/FVC \< 0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 µg of salbutamol).
* Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at screening.
* Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).

Exclusion Criteria:

* Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) .
* Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.
* Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.

Other protocol-defined inclusion/exclusion criteria may apply
ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).


Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age at time of consent
* Have a body mass index (BMI)of 19 to 35 kg/m2 at screening
* Are receiving prescribed opioid medication for the management of chronic, non-cancer pain
* Meet the criteria of OIC
* Agree to use an acceptable method of contraception for the duration of the study

Exclusion Criteria:

* Pregnancy and/or currently breastfeeding
* Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)
* Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction
* Any gastrointestinal (GI) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction
* Use of naloxone, Subutex or Suboxone, Revia, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study
* Participation in a clinical trial of a pharmacological agent within 30 days before screening
Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy

The aim of this study is to determine which of two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in cancer survivors. The investigator also wants to study the factors that might impact why someone might prefer or do better in one treatment over the other.

Group 1 will get Acupuncture - Acupuncture is an ancient Chinese Technique of using very thin needles inserted in the skin to treat different symptoms and illness, and to promote healing.

Group 2 will get Cognitive Behavioral Therapy for Insomnia (CBT-I) - CBT-I is a treatment to address behaviors and thoughts that are known to effect problems with sleep.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking, age ≥ 18 years old
* A diagnosis of cancer with no restrictions placed on type of cancer or stage. Eligibility criteria are not be restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is sufficient for other study sites.
* Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment or maintenance targeted therapies will not be excluded).
* A score \>7 on our primary outcome (the Insomnia Severity Index)
* A diagnosis of insomnia disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5), per the diagnostic interview. According to this nosology, insomnia is defined as dissatisfaction with sleep quality or quantity characterized by difficulty initiating sleep, maintaining sleep, or early morning awakenings that cause significant distress or impairment in daytime functioning and occur at least three nights per week for at least three months despite adequate opportunity for sleep.
* Patients using psychotropic medication (e.g. antidepressants) will remain eligible for study participation provided that the dose was not recently altered (stable over the previous 6-weeks).
* Patients using hypnotics or sedatives will be eligible for study participation. Considering the high use of benzodiazepines within the oncology population, past research has included participants who met diagnostic criteria for insomnia, despite the use of benzodiazepines, and included monitoring of medication use.

Exclusion Criteria:

* Another sleep disorder, other than sleep apnea, that is not adequately treated.
* Previous experience with CBT or acupuncture to treat insomnia
* Currently participating in another acupuncture trial or a trial to treat insomnia
* The presence of another Axis I disorder not in remission
* Employment in a job requiring shift work that would impair the ability to establish a regular sleep schedule
* Patients who are currently taking oral (not including oral sprays/inhalers) or intravenous corticosteroids as part of treatment for cancer or any other condition will be excluded because of the potential of these drugs to induce insomnia
Chemically Assisted Capsulectomy-A New Clinical Approach

The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.

Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.

Eligibility Criteria:
Inclusion Criteria:

* All females undergoing capsulectomy

Exclusion Criteria:

* All pregnant women and nursing mothers will be exclued