cyrilzakka/clinical-trials huggingface dataset:
Italian Study on the Right Hemicolectomy: How the Lymphadenectomy is Performed

The objective of the study is the analysis of lymphadenectomy in the course of right hemicolectomy, in relation to the radicality of the surgical resection that is performed. In particular, the investigators wants to inquire how according to precise standards regarding surgical radicalness and consequently the anatomical piece that is obtained it is possible to correlate a certain number of lymph nodes and their possible positivity.

The lead center is the General and Thoracic Surgery Department of the University of Ferrara. Prof. Anania is the responsible for the enrollment of patients and the coordination with the collaborating centers in the six month-study

All the high-volume specialist centres that perform this type of intervention in Italy will be invited, with a minimum number of 25 interventions per year. At the end of the study 788 patients was enrolled.

The data of the patients involved will be collected independently and anonymously by the individual centers involved, using a common alpha numeric code decided by the coordinating center.

The parameters examined will be:

* Personal data of the patient
* Stage of neoplasm due to surgery
* Type of surgery and duration
* Post-operative course
* Presence of post-surgical complications and eventual hospital readmission due to these complications
* Study of the operating piece and lymphadenectomy performed:

Tumor free margin Terminal ilium length The different vascular ligatures and levels at which they are performed Integrity of the mesocolon Number of positive nodes per total removed

Following the end of the 6 months of observational study period, the data will be processed anonymously at the coordinating centre.

Eligibility Criteria:
Inclusion Criteria:

* Patients and/or legal guardians, where applicable, have been fully informed and have voluntarily provided informed written consent or patients unable to read and/or write who have fully understood the information verbally provided by the investigator and who have provided a verbal consent testified in writing by a third person.

  * Patients aged \> 18, men and women, operated by laparoscopic right hemiolectomy or video assisted, under election regime at the U.O. General and Thoracic Surgery with diagnosis of colic adenocarcinoma at any stage.
  * Patients who have already undergone chemotherapy and radiotherapy for other reasons.

Exclusion Criteria:

* Under age.
* Patients undergoing emergency surgery.
* Women who are pregnant.
* Patients with right-handed laparotomy
Sugars in Cigarettes

To investigate a comprehensive set of abuse liability and appeal measures, smoking intensity, as well as analyze the impact of sugar content on the formation in the oral cavity of smokers of DNA adducts derived from aldehydes and oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 21 years or older
* Smoking cigarettes that have been evaluated to have medium levels of sugar content
* No quit attempts in the past month nor intentions to quit smoking in the next month
* Participants are in good physical health (no unstable medical conditions) as determined by the licensed medical professional
* Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis) as determined by the licensed medical professional
* Stable vitals sign measurements (systolic BP ≤ 160 and \>90 mmHg, diastolic BP ≤ 100 and \>50 mmHg and heart rate ≤105 and \> 45 bpm) as determined by the licensed medical professional
* Participants must be able to read for comprehension or completion of study documents (confirmed during informed consent process)
* Participants have provided written informed consent to participate in the study.

Exclusion Criteria:

* Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
* Women who are pregnant or nursing or planning to become pregnant.
Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)

The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.

Acronyms in the Adverse Event Section:

* IUCD Intrauterine Contraceptive Device
* MedDRA Medical Dictionary for Regulatory Activities

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer HealthCare AG, Germany.

Eligibility Criteria:
Inclusion Criteria:

* Women who have \>/= 80 mL blood loss during their menstrual cycles and desire contraception

Exclusion Criteria:

* Post menopausal menstrual cycle \< 21 days or \> 35 days
* Pregnancy
Point-Of-Care Ultrasound-Driven vs Standard Diagnostic Pathway in Emergency Department Patients With Dyspnea

The POCUS PATHWAY-trial is a multi-center, randomized, investigator-initiated, open labelled, pragmatic, controlled trial of a point-of-care ultrasound-driven diagnostic pathway vs standard diagnostic pathway in dyspneic emergency department patients. The primary outcome will be 24-hour hospital stay and 642 patients will be included. Key secondary outcomes include overall hospital length of stay, image resources, and 72-hour revisits.


Eligibility Criteria:
Inclusion Criteria:

1. Emergency department contact
2. Age ≥ 18 years
3. Chief complaint is Dyspnea
4. Including physician present

Exclusion Criteria:

1. Fulfilling of criteria for coded rapid-response teams (i.e., trauma, surgical or medical emergencies).
2. Prior focused lung or focused cardiac ultrasound in the current emergency department stay
3. Prior enrollment in the trial
4. Unable to consent
5. Non Danish-speaking
Follow-up Care After Treatment for Endometrial Cancer

The purposes of this study are to examine the needs (symptoms, support, information) and satisfaction of women during follow-up in the community after completing treatment for endometrial cancer. This information will be collected from the perspective of the women themselves, their primary care providers (family physician or gynecologist) and the health care providers (oncologist, nurses, social worker, psychologist) at the cancer centre.

Research Question How has this transfer in follow-up care impacted performance indicators?

* Volume of follow-up care transferred
* Percentage of women, who have required a re-entry consultation
* Fiscal implication of this transfer of follow-up care

Patient stakeholders:

* What are women's perceptions of the transition of follow-up care?
* What are women's supportive care needs during the transition of follow-up care and ongoing needs?

Primary Care Practitioner stakeholders:

* What are the primary care practitioners' perceptions of the process of transition of follow-up care?
* What are the primary care practitioners' educational needs?
* What are the primary care practitioners' perceptions of the process of re-entry for in women with suspected recurrence?

Tertiary Centre: Health care providers stakeholders

o What are the perceptions of tertiary health care providers about the transition of follow-up care?

Eligibility Criteria:
Inclusion Criteria:

* Participants- women diagnosed with endometrial cancer:

  * 18 years of age or older.
  * speak English or French
  * who have been treated (surgery and/or radiation therapy) at TOH.
  * who have been discharged from follow-up in the cancer centre in the past 6 months.
* Participants-primary care provider practitioner:

  * providing follow-up care to at least one woman with endometrial cancer
* Participants- health care providers at the tertiary centre :

  * physicians, nurses or allied health care providers whose primary responsibility are to provide care to women with gynecological cancer.

Exclusion Criteria:
Effects of the Anti-HIV Pill Truvada on Gene Transcription in the Gastrointestinal Tract of HIV-uninfected Individuals

As explained in detail in a recently published hypothesis article (Hladik F. A new hypothesis on HIV cure. F1000Research, 4:77 (2015)), the investigators hypothesize that NRTI drugs may reduce the likelihood of HIV eradication by promoting the survival of cells with integrated provirus. In this study, the investigators will test whether daily oral use of two NTRI drugs, tenofovir and emtricitabine (Truvada Pill), induces changes in the upper and lower gut mucosa that are congruent with supporting this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* • HIV-negative

  * Male gender at birth
  * Age ≥18 years old
  * Intent to initiate PrEP in the next 1-2 months.
  * Willingness and ability to provide informed consent for study participation
  * Willingness to undergo all required study procedures

Exclusion Criteria:

* Creatinine clearance \< 60mL/min
* Platelet count below the normal reference
* Coagulation (PT/PTT) tests above the normal reference
* Any prior use of PrEP
* Use of PEP within 30 days prior to study entry
* Receipt of

  * anti-coagulant medications (e.g. warfarin). Aspirin is allowable.
  * Systemic corticosteroid medications
  * Non-steroidal anti-inflammatory drug (NSAID) use \>2 days/week
* Signs or symptoms of acute HIV infection within 14 days of study entry
* No availability of another person who will drive participant home on days of entry and follow-up procedures.
* Plan to leave the Seattle area in the subsequent 2.5 months
* Any condition or substance use that, in the opinion of the study investigator, would interfere with study participation.
Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section

This study aims to evaluate the effect of local administration of bupivacain in the cesarean section incision for postoperative pain control, using the visual analogue pain scale (VAS) and assessing the need for rescue analgesia after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≥ 36 weeks
* Elective cesarean section
* Transverse segmental caesarean section Pfannenstiel type
* Spinal anesthesia
* Maternal age 18 to 45 years
* Any gravaparity
* Patient ASA I or II

Exclusion Criteria:

* Any patient who does not meet the inclusion criteria.
* Emergency cesarean section
* History of chronic or neuropathic pain
* Patient with cardiopulmonary disease
* Known allergies to the drugs used in the study
* Patient who does not wish to participate in the study
Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer

This study seeks to determine the clinical impact of Gene Expression Classifier (GEC) testing in prostate cancer care while also developing a pragmatic approach for improved GEC clinical use and future study.

All patients in this study have received or will receive a score from the Michigan Urological Surgery Improvement Collaborative's Cancer of the Prostate Risk Assessment (askMUSIC) scoring system, at the time of enrollment. AskMUSIC is a risk calculator based on standard clinical and pathologic variables and is generally included as part of routine clinical care. The variables used in the risk calculator are prostate-specific antigen (PSA), Gleason score, number of positive core biopsies, number of negative core biopsies, and clinical stage.

Patients will be randomized to either an intervention arm or a control arm. In the control arm, the treating provider will review the askMUSIC score with the patient. In the intervention arm, the treating provider will review the askMUSIC and the GEC score with the patient. Biopsies obtained during the course of standard clinical care will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx Genomic Prostate Score. No additional biopsies will be obtained as part of this study.

After reviewing the results, patients and their treating physicians will decide on a management strategy.

Long-term follow-up will be tracked through the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months.
* Prostate biopsy tumor tissue (FFPR block) available for processing
* Age 18 years or older
* PSA \<20 ng/ml
* Grade Group (GG) 1 cancer with \> 2 biopsy cores involved with cancer OR GG2 cancer
* Ability to understand and the willingness to sign a written informed consent. A subject's legally acceptable representative may sign the consent form.

Exclusion Criteria:

* Clinical (on digital rectal exam) or radiographic evidence (if MRI performed) of T3 disease
* Nodal or metastatic prostate cancer (if staging imaging performed)
* Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy.
* Prior prostate gene expression classier testing
Coronary Artery Disease and Sleep Apnea

The purpose of this study is to determine the effect of sleep apnea on mortality, stroke and myocardial infarction among 408 patients with coronary artery disease referred for evaluation of coronary intervention who were examined with overnight cardio respiratory monitoring between March 1992 and June 1995.


Eligibility Criteria:
Inclusion Criteria:

* Men and women younger than 70 with disabling angina pectoris and coronary disease according to coronary angiography.
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin

Primary Objective:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus

Secondary Objectives:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

The maximum study duration was up to approximately 58 weeks per participant, consisting of:

* up to 2 week screening period
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 4-week safety follow-up period in a subset of participants
* a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300

Eligibility Criteria:
Inclusion criteria :

* Participants with type 2 diabetes mellitus
* Substudy inclusion criteria:

  * Completion of the 6-month study period in main study (Visit 10)
  * Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)

Exclusion criteria:

* Age less than (\<) 18 years
* HbA1c \<7.0% or greater than (\>) 10% at screening
* Diabetes other than type 2 diabetes mellitus
* Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose
* Any contraindication to use of insulin glargine as defined in the national product label
* Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit
* Use of an insulin pump in the last 6 months before screening visit
* Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit
* History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
* Pregnant or breast-feeding women or women who intend to become pregnant during the study period
* Substudy exclusion criteria:

  * Participant not willing to use the adaptable injection intervals on at least two days per week

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Cardiac Resynchronisation Study

This study aims to investigate the effect of a pacemaker device used in heart failure patients which is called Cardiac Resynchronisation Therapy (CRT). Specifically the investigators aim to investigate if the CRT pacemaker has an effect on breathing stability in these patients and particularly breathing stability at night. Our theory is that the CRT pacemaker may improve the stability of breathing in patients with heart failure.

AIM To investigate the effect of Cardiac Resynchronisation Therapy (CRT) on chemosensitivity in patients with Chronic Heart Failure with and without Sleep Disordered Breathing (SDB).

OBJECTIVE To conduct a physiological observational study to measure hypercapnic ventilatory responses in a group of CHF patients before and 3 months after implantation of clinically indicated CRT devices. Additionally to conduct nocturnal polysomnography to establish if any change in chemosensitivity is related to the presence of SDB at baseline and, where present, any change in SDB after implantation.

HYPOTHESIS Primary hypothesis: CRT implantation will be associated with a reduction in the hypercapnic ventilatory response from baseline to 3 months post implantation.

Additional hypothesis: This reduction in hypercapnic ventilatory response after CRT implantation will be greatest in those CHF patients with SDB at baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. Fulfil the current guidance for the implantation of a CRT device; optimal medical treatment for heart failure, broad QRS complex on electrocardiogram with or without evidence of cardiac dyssynchrony as appropriate, LVEF \<35%, functional impairment as defined by an NYHA class of III-IV
3. Clinically stable with no unplanned admission to hospital for preceding 4 weeks
4. No changes in medications for heart failure in preceding 4 weeks
5. Able to read and understand patient information sheet and give informed consent

Exclusion Criteria:

1. On positive pressure treatment for known sleep disordered breathing at the time of inclusion
2. Other known condition (untreated) likely to significantly disturb sleep eg. Restless legs syndrome, pain from any cause etc.
3. Pregnancy
Compression Device Safety Study

To evaluate the safety of the Compression Device to subjects with venous insufficiency and oedema.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years, willing and able to provide written informed consent.
* Subjects able to wear the Amadeus device and follow the requirements of the clinical investigation plan
* Subjects who have an ankle to brachial pressure index (ABPI) of ABPI \>0.8
* Subjects with chronic lower limb oedema (i.e. CEAP classification of C3, C4 or C5 1.)
* Subjects who have Chronic Venous Insufficiency (CVI), which has been present for 6 weeks or longer and who have refluxes \>0.5 sec in one or more major venous segments, superficial or deep or both (CEAP classification: C3-C5 1.; Ep,s; As,d; Pr).

Exclusion Criteria:

* Subjects with a history of skin sensitivity to any of the components of the study product.
* Subjects who have previously been entered into the study before
* Subjects who have a history of Deep Vein Thrombosis (DVT) within the last 6 months
* Subjects who have an active leg ulcer (i.e. CEAP classification of C6 1).
* Subjects with active cardiac disease or significant history of cardiac disease (including history of myocardial infarction, heart failure, valvular disease, arrhythmia and those with a pacemaker or have previously had a pacemaker).
* Subjects who have initiated treatment or changed the dose within the past month of pharmaceutical agents that reduce clotting e.g. aspirin (except low-dose aspirin), anti-platelets, anti-coagulants and coumarin.
* Subjects who are currently taking pharmaceutical agents that can modify the amount of leg oedema (e.g., diuretics, dihydropyridine calcium channel blockers, phlebotonic drugs, or fluctuating doses of systemic steroids) or have taken these agents within the last 10 days.
* Subjects who are pregnant
* Subjects who have worn compression therapy in the last 48 hours
* Subjects who have leg sizes outside the following range:

  * Ankle 17cm - 32cm
  * Calf 27cm - 47cm
  * Below Knee 29cm - 51cm
Group Interventions for Breast Cancer Survivors

The purpose of this study is to compare two types of groups for breast cancer survivors: a Meaning-Centered Group and a Discussion Group. Many breast cancer survivors seek help to deal with the emotional burden of having gone through the cancer experience. Participation in groups offering support often helps cancer survivors cope with stressors of life after having had cancer by giving them a place to express their feelings. The "Meaning-Centered Group" is intended to teach breast cancer survivors how to maintain or even increase a sense of meaning and purpose in their lives after treatment for cancer. The "Discussion Group" is intended to help breast cancer survivors cope by giving them a place to get support from other breast cancer survivors.

The goal of this study is to compare the benefits of these two types of group approaches for breast cancer survivors. The study is also testing the benefits and feasibility of conducting the groups virtually using a telephone and computer.


Eligibility Criteria:
Inclusion Criteria:

* History of non-metastatic breast cancer (DCIS or Stage I, II, or III) as recorded in the medical record at MSKCC by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
* Post completion of treatment (may be on hormone therapy, such as Tamoxifen or monoclonal antibody, such as Herceptin or Pertuzumab)) for any type of cancer as confirmed by the medical record at MSKCC, by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
* Age 18 or older
* Access to a telephone, computer (e.g. desktop, laptop, smartphone, tablet) and Internet

For Phase 2 only:

* A score of ≥ to 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the patient's breast cancer or survivorship
* If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study PI/co-PI or, confirmed by reports in the medical record at MSKCC, by selfreport, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
* Did not participate in Phase 1

Exclusion Criteria:

* Evidence of or treatment metastatic disease
* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the groups (i.e., acute psychiatric symptoms which require individual treatment).
Eccentric Strength Training of Ankle Joint Muscles in Swimming

This study was conducted to investigate the effectiveness of ankle muscle strengthening program of 8 weeks on the underwater dolphin kick performance in young swimmers. This study was a randomized controlled trial. Swimmers was divided in two groups; eccentric ankle muscle-strengthening exercises and control group. The outcome measures were strength of plantar flexors, dorsal flexors, internal rotators, external rotators and 5-meter underwater dolphin kick time.

There is limited information on the effectiveness of ankle joint muscles in respect to the knee, hip, back and upper extremity muscles creating the propulsive forces for the feet to transfer the moment force towards water. Therefore, it is aimed to observe the effects of eccentric ankle muscle-strengthening exercises given by means of elastic bands on the Underwater Dolphin Kick performance of young swimmers.

Eligibility Criteria:
Inclusion Criteria:

* Having swimming training at least three times per week for the last year and using the proper UDK technique, which was assessed by the swimming trainer of the participants.

Exclusion Criteria:

* having any lower extremity injury or low back pain.