cyrilzakka/clinical-trials huggingface dataset:
Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids

The primary objective of this study is to evaluate the efficacy of topical 2% lidocaine in the therapy of symptomatic hemorrhoids. Efficacy will be determined by:

1. the change from baseline in pain, itching, bleeding, swelling, discomfort, general well-being and improvement since the beginning of treatment as separate components of CORRECTS scale
2. the change in overall CORRECTS values from baseline
3. the change in degree of hemorrhoids from baseline

This is a double blinded randomized clinical study into the effect of topical 2% lidocaine in patients with symptomatic hemorrhoids.

Calculated sample size is 69 patients per arm, based on expected improvement of pain and healing by 30% at p\<0.05 and power goal of 95%. Taking into account a drop-out rate of 50%, total number of 69 patients in each arm is estimated as sufficient to close the study.

Patients will be randomly assigned into 2 arms, arm 1 (treatment): topical 2% lidocaine and arm 2 (control): vaseline base. Each arm will consist of 69 patients. Patients will be assigned to either treatment or control arm according to the randomization table.

* Treatment arm - topical 2% lidocaine. Topical application of 2% lidocaine in vaseline base repeated two times per day,
* Control arm - vaseline base. Topical application of pure vaseline base twice per day.

In addition to the aforementioned topical treatments, all patients will be given written instructions to perform dietary modifications and anal hygiene. All patients with bleeding hemorrhoids will be given Detralex 2 tablets twice per day.

Those patients in whom a technically successful procedure has been completed will be considered as valuable for the efficacy evaluation. A technically successful procedure is defined as the completion of treatment procedures stipulated in this protocol and consists of correct drug dose and frequency of application, adherence to written instructions for dietary modification and anal hygiene and presence at follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* clinically present enlarged hemorrhoids, grade 1-4 (for definition see Appendix 1)
* symptoms of pain or itching
* age 18 years or more
* willing and able to comply with the study
* geographically suitable, meaning with reliable transportation for outpatients to the testing site

Exclusion Criteria:

* actual pregnancy
* inability to provide informed consent
* any anal topical medication applied in the last 7 days
* any anal surgery (including surgical or instrumental procedures defined in the section 4.3) in the last 60 days
* known allergy to vaseline, lidocaine or Dulcolax
* other anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections
* contraindication for topical anal application of vaseline or lidocaine
Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Study 2)

This study is being done to test the comparative effectiveness of participating in a Pulmonary Rehabilitation Program at home using new technology and health coaching following dismissal from the hospital compared to the referral to a center based pulmonary rehabilitation that may include the choice of center based or telehealth.

Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. After the COVID epidemic, telehealth is an option for individuals referred to patients referred to center based rehabilitation.

The direct referral to home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective. The refined home-based PR program from the pilot portion of the study supported by a separate grant mechanism (R61HL142933/NCT03865329) will be tested in this second part randomized control study.

Subjects with a COPD-related hospitalization (exacerbation or pneumonia) will be randomized after hospital discharge to either home-based PR or Choice (referral to conventional center-based PR or telehealth-based PR).

Eligibility Criteria:
Inclusion Criteria:

* COPD related hospitalization and eligible for PR
* Age 40+
* Confidence (score \> 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)

Exclusion Criteria:

- Inability to walk (orthopedic-neurologic problems or confined to bed)
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects

This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator.
* Body Mass Index (BMI) between 19-29 kg/m\^2 (inclusive)
* Fasting plasma glucose between 3.8-6.0 mmol/L (both inclusive)

Exclusion Criteria:

* Clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator or Sub-Investigator
* Any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
* Any inter-current illness that might affect blood glucose, as judged by the Investigator or Sub-Investigator
* Hepatitis B or C, or HIV (human immunodeficiency virus) positive
* Subjects with a first degree relative with diabetes mellitus
* History of or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
* Subjects who consumed more than 28 units of alcohol per week or who had a significant history of alcoholism or drug/chemical abuse
* Subjects who smoked more than 5 cigarettes per day
* Subjects who had taken part in strenuous exercise within 7 days prior to the screening
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe rheumatoid arthritis
* Taking methotrexate without adequate control of symptoms
* Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)

Exclusion Criteria:

* Current or recent infection
* Clinically significant laboratory abnormalities
* Pregnancy
Detection in Peripheral Blood of Circulating Tumor Cells in Patient With Head and Neck Squamous Cell Carcinoma

The dissemination of individual tumor cells is a common phenomenon in solid cancers. Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic situation is of high prognostic significance.

The objective of our study was to detect circulating tumor cells in two different method in patient with head and neck squamous cell carcinoma .


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with head and neck squamous cell cancer stage III or IV histologically proven
* Patient naive to any prior therapy
* Patient with operate cancer and resectable tumor
* Hemoglobin ≥ 10g / dL
* Performance status ≤ 2
* Ability to provide written informed consent
* Patient's legal capacity to consent to study participation

Exclusion Criteria:

* Other previous histology tumors
* Medical conditions or acute or chronic severe psychiatric disorders
* Deprived of liberty or under supervision
Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury

The purpose of this study is to evaluate delayed myocardial protective effect of RIPC in patients undergoing cardiac valve replacement surgery.

Ischemic preconditioning is one of the strategies that can reduce perioperative myocardial injury. It is a concept that briefly induced ischemia and reperfusion before the myocardial injury can reduce the myocardial injury. But it is difficult to apply ischemic preconditioning in operative field, because cross-clamping of aorta or coronary artery is difficult and invasive. Afterward concept of remote ischemic preconditioning(RIPC) has introduced that ischemia of remote organs like kidneys, skeletal muscles can reduce distant myocardial injury.

It is known that myocardial protective effect of ischemic preconditioning have biphasic pattern. Early protective effect wanes after a few hours, then recurs after 24-48 hours, and can persist for up to 3-4 days. It is called second window of preconditioning or delayed ischemic preconditioning. Delayed ischemic preconditioning is similar to early ischemic preconditioning in mechanism but it is different that it produces protein that can mediate myocardial protection effect.

Unlike ischemic preconditioning, it is little known about delayed effect of RIPC. RIPC can be done by applying compression cuff on upper or lower extremities and it is noninvasive and easy to deliver compared to ischemic preconditioning that is done by aorta or coronary artery clamping.

Delayed ischemic preconditioning is performed one day before the surgery, and it is safe and easy to apply RIPC in a clinical setting. And in this study investigators are going to evaluate cardioprotective effect of delayed RIPC. Myocardial injury can be predicted by elevation of cardiac enzyme. Investigators are going to perform RIPC one day before the valve replacement surgery and compare troponin I with control group to assess cardioprotective effect of delayed RIPC.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 80 years of adult patient undergoing cardiac valve surgery

Exclusion Criteria:

* Patient who did not agree to the study
* Emergency operation
* Using inotropics, mechanical assisting device
* Severe liver disease (\>Child class II )
* Severe renal disease (Renal replacement therapy)
* left ventricular ejection fraction \< 30%
* Co-operation of major surgery (Carotid endarterectomy )
* Oral hypoglycemic agent (Sulfonylurea, Glibenclamide)
* peripheral vascular disease affecting upper extremity
Improving Behavioral Health Care for Children With ADHD

The purpose of this study is development of the Integrative Pediatric FPA ADHD Care (IPFAC) Model. The IPFAC is intended to increase access to evidence-based behavioral parent training (BPT) for school-age children diagnosed with attention-deficit/hyperactivity disorder(ADHD) who are diagnosed with ADHD and served in the ADHD Clinic at NYU Bellevue's Department of Developmental and Behavioral Pediatrics.

The specific aims of this study are to: 1) Develop the IPFAC model (Phase I); 2) Assess and determine facilitators and barriers to fidelity, assess feasibility of data acquisition, determine preliminary efficacy, and refine the IPFAC model through a small-scale implementation study and Plan-Do-Study-Act methods (Phase II), and, 3) Evaluate the revised IPFAC model in a small-scale study using state-of-the-art single-case study design methods/analyses to test "treatment mechanisms" in a sample of newly diagnosed youth with ADHD (Phase III) and finalize the IPFAC procedural manual.

Eligibility Criteria:
Inclusion Criteria:

* being a parent of a child who is a patient at the NYU Bellevue ADHD Clinic
* being an adult over the age of 18
* having a child who obtained a diagnosis of ADHD (any subtype) within the previous 3 months (ie.., newly diagnosed) through the NYU Bellevue ADHD Clinic
* parent must speak English and/or Spanish.

The second study participant is the child. Study inclusion criteria for children include:

* child is a patient at the NYU Bellevue ADHD Clinic
* child is between the age of 6-11
* participating child must have obtained a diagnosis of ADHD (any subtype) within the previous 3 months (i.e., newly diagnosed) through the NYU Bellevue ADHD Clinic,
* child must speak English and/or Spanish.

Exclusion Criteria:

* parent presenting with severe mental health illness (e.g., schizophrenia; bipolar disorder) that would warrant immediate services.
* child with primary diagnosis/presenting issues of severe mental illness (e.g., schizophrenia; bipolar disorder) that would warrant primary services other than what is offered through the project.
Study of Arimoclomol in Patients Diagnosed With Gaucher Disease Type 1 or 3

Multicenter, doubleblinded, randomized placebo-controlled study of arimoclomol in patients with Gaucher Disease Type 1 or 3

Evaluating the response of 3 dose levels of arimoclomol on various pharmacodynamic biomarkers in blood and cerebrospinal fluid as indicators of enhanced GBA in Gaucher Disease Type 1 or 3.

Eligibility Criteria:
Key Inclusion Criteria:

* Be able to understand and voluntarily sign informed consent
* A diagnosis GD, either Type 1 or Type 3
* For GD3 at least 1 neurological symptom
* Age ≥ 4 years and ≤ 60 years at the time of enrolment
* Plasma or serum chitotriosidase activity greater than 3 times the upper limit of normal.

Key Exclusion Criteria:

* Recipient of a liver transplant or planned liver transplantation during the course of the study.
* Splenectomy within 4 months of study entry or planned splenectomy during the course of the study.
* Severe liver damage.
* Severe renal insufficiency.
* Body weight \< 10 kg.

Other inclusion and exclusion criteria may apply
A Single-Patient Study Using AGS 006

Argos Therapeutics, Inc., (Argos) proposes to study AGS-006 in a subject with newly diagnosed resectable pancreatic cancer. The AGS 006 immunotherapeutic may potentially offer a desired additional option to conventional treatments for pancreatic carcinoma.

Single-patient, open-label clinical study:

* Events during Pre-Treatment Period:

  1. Resection of pancreatic cancer,
  2. RNA acquisition from tumor specimen,
  3. RNA amplification,
  4. Infectious disease testing,
  5. Autoimmune disease testing,
  6. Two blood draws for immune response monitoring,
  7. Production leukapheresis, and
  8. Dendritic cell electroporation with RNA and immunotherapeutic production;
* Events during Induction Period:

  1. Administer investigative treatment every 2 weeks for a total of five doses, followed by dosing every 4 weeks for a total of four doses,
  2. Two Induction Period blood draws (Week 6 and Week 12) for immune response monitoring, and
  3. One leukapheresis (Week 14) for immune response monitoring;
* Events during Booster Period:

  1. Dose every 3 months until progression or 2 years after first AGS treatment,
  2. Potentially, one leukapheresis for immune response monitoring 12 months from the first dose, and
  3. One blood draw 2 weeks following dosing at Week 36 (1st booster dose) (approximately Week 38); and,
* Events during study Close-Out:

  1. Close-Out upon progression or 28 days following immune response monitoring 2 years after first dose

Eligibility Criteria:
Inclusion Criteria:

* A male subject 18 years of age or older with newly diagnosed resectable pancreatic cancer who, in the opinion of the investigator, is suitable for participation in the study will be eligible for inclusion if all of the following criteria apply:

  1. Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
  2. Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
  3. Voluntary informed consent given to participate in the study.

Exclusion Criteria:

1. Any serious medical condition such as cardiopulmonary disease, circulatory compromise, hepatic or renal dysfunction, or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
2. Active autoimmune disease including, but not limited to:
3. Active, acute, or chronic clinically significant infections including human immunodeficiency virus (HIV) and viral hepatitis.
4. Known hypersensitivity to dimethyl sulfoxide (DMSO).
5. Body weight less than 30 kg.
The Journey of Children With Cow's Milk Protein Allergy in Mexico.

To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the methodology used by Mexican Health Care Professionals (HCPs) in the clinical practice (i.e. diagnosis and dietary management) of CMPA in Mexican children (≤24 months) diagnosed with or suspected of CMPA.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with electronic/physical medical records that contain sufficient data to answer the primary question (i.e. data on growth and dermatological symptoms (based on the SCORAD score) at diagnosis and follow up data of at least 2 months or successful completion of therapy according to the PI (whichever comes first).
* Subjects ≤24 months of age at the moment of suspected or diagnosed CMPA with records available between January 2016 to September 2020.
* Subjects prescribed with Frisolac Gold Intensive HA and/or Frisolac Gold PEP AC for the dietary management of their CMPA symptoms.

Exclusion Criteria:

* Subjects using other formula products/breast milk alongside Frisolac Gold Intensive HA or Frisolac Gold PEP AC during the time of their participation in the study.
* Premature children, or children with low birth-weight (weight at birth \<2.5 kg).
* Subjects diagnosed with a metabolic condition that impacts development and growth.
* Subjects diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the PI could potentially interfere with their participation in the study.
Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy for Patients

LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, postoperative mortality, mobility and recovery of liver function are associated with major blood loss which is always the main cause of conversion to laparotomy and remains a challenge for surgeons. Pringle first described the method to arrest the hepatic hemorrhage by compression of the porta hepatis and this procedure was widely spread as well as in laparoscopic feild currently. Here, we described a new modified of Pringle maneuver using Bulldog to block vascular during LLR, and compared its effects with traditional pringle maneuver.

With the innovations of laparoscopic technique and specialized equipment , laparoscopic liver resection became the dominating resection surgery approach. December of 2014, laparoscopic hepatectomy was carried out in our department, extracorporeal Pringle maneuver has been applied in most laparoscopic liver resections which need to block the hepatic inflow, cotton tape was the frequently used tourniquet. We used to blocked the hepatic inflow by extracorporeal Pringle maneuver method with cotton tape for its validity , softness and no visible damages for vessel, but it was always difficult for clamping in a two-dimensional view to encircle the hepatoduodenal ligament , and it delayed operation time for freshmen. Bulldog has been widely used in urinary surgery for vascular occlusion, but bulldog in hepatic surgery has rarely been mentioned, this is the first report to formally demonstrate the clinical application in hepatic surgery. However, it is not clear that whether the bulldog for vascular occlusion is useful and easy to implement in laparoscopic hepatectomy. In this study, we will compare the cotton and the bulldog for vascular occlusion during laparoscopic hepatectomy

Eligibility Criteria:
Inclusion Criteria:

* Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for laparoscopic liver resection
* Child-Pugh A without portal hypertension
* No portosystemic shunt
* No previous abdominal operation history
* American society of anesthesiology class(ASA): I or II
* Age 18 to 80

Exclusion Criteria:

* Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
* Emergence hepatectomy
* Previous hepatectomy
* Combined operation for extrahepatic disease
* Vulnerable population (mental retardation, pregnancy)
Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness

The purpose of this study is to establish a registry of survivors of cancer, tumor, or a related illness.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* A personal history of cancer tumor, or a related illness
* Followed in the the Adult Long Term Follow Up Program, Pediatric Long Term Follow Up Program, or Lymphoma Service at MSKCC

Exclusion Criteria:

* Evidence of active progression of disease or recurrence
* Neurocognitive deficits that impair ability to give informed consent.
Clinical Characteristics of Aquagenic Pruritus in Patients With Myeloproliferative Neoplasms

Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms.

Prospective work based on the distribution of a dedicated questionnaire.

Patients with myeloproliferative neoplasms identified and followed in our Institution (Brest University Hospital). Patients could be followed for polycythemia vera or essential thrombocythemia or myelofibrosis.

Distribution of the questionnaire to each patients with myeloproliferative neoplasms (treated or not) suffering from aquagenic pruritus.

Analyse of each characteristic of the aquagenic pruritus by a statistician and publication at the end.

Eligibility Criteria:
Inclusion Criteria:

* patients followed with myeloproliferative neoplasms
* suffering from aquagenic pruritus

Exclusion Criteria:

* Unable to fulfil the questionnaire
* No written informed consent