cyrilzakka/clinical-trials huggingface dataset:
Learning Curve for Laparoscopic Distal Pancreatectomy

Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions has recently becoming the treatment of choice in experienced centres. No data have been published about learning curve so far. The purpose of this study was to identify the learning curve period for performing LDP.

Between March 2009 and August 2010 all patients with lesion of body or tail of pancreas were assessed for eligibility for LDP. Exclusion criteria were: major vessels contact in cancer patients, severe organ dysfunction, BMI \> 35, and refusing laparoscopic approach. All laparoscopic procedures were carried out by the same surgical team with large experience in open pancreatic surgery. All patients were treated according to an early recovery after surgery protocol. Primary endpoint was conversion rate. Secondary endpoints were operation time, operative blood loss, postoperative morbidity, and length of stay.

Eligibility Criteria:
Inclusion Criteria:

* pancreatic lesion located at body or tail

Exclusion Criteria:

* major vessels infiltration
* severe organ dysfunction
* refusing laparoscopic approach
Neurological Features During COVID19

Description of the neurological impairment: clinico-radiological and electrophysilogical correlations

Describe short and long term clinical radiological and electrophysilogical presentations of neurological damage central and peripheral SARS COV2 infection Describe the association between neurological, respiratory and dysautonomic Determine the prognosis of neurological damages to short and long term.

Eligibility Criteria:
Inclusion Criteria:

* PCR SARS COV2 positive or CT Scan
* Central neurological signs such as confusion, epilepsy, abnormal movement, pyramidal signs, motor or sensory deficit, involvement of cranial pairs (such as anomie or ageusia) or peripheral.
* Dysautonomic signs such as hypotension or hypertension, bradycardia or tachycardia, hypothermia, SIADH not explained by therapy or a pathology other than SARS COV 2 infection

Exclusion Criteria:

* Contraindication to performing an MRI scan
* Minor
* Pregnant woman
* No follow-up possible at 6 months
Patient Derived Preclinical Models

Study goal is to collect tumor specimens that may inform cancer biology to eventually improve outcomes for patients with cancer. This proposal represents a highly collaborative effort to support cancer research with the goal of developing novel therapeutic strategies using patient derived preclinical models.

This study is being done to collect samples of tumor tissues, matched normal tissue when possible, and approximately 50 mL of blood.

The objective of this study is to collect tumor specimens (tumor tissues, matched normal tissue when possible, and 50 mL of blood) that may inform cancer biology to eventually improve outcomes for patients with cancer. Additionally, relevant specimens that were previously collected under an IRB approved protocol (13-000942), will be used with approval of the PI of that protocol and patient consent for participation in this protocol.

The collected tissue specimens will be used to develop preclinical models; i.e., cell lines, patient derived micro-cancer models as well as patient-derived xenograft models. In this study we may profile tumors using genomic and/or proteomic approaches to identify targetable alterations in tumor tissue from patients. To assure that the derived cell lines and micro-cancer models have not been cross contaminated during development with other models in development, DNA sequencing may be used. Using these preclinical models, we will test new therapies in vitro, or in vivo in mice in order to identify novel therapeutics as well as interrogate genes for their role in tumor biology. Guidance for molecular targeted therapy will involve gene analysis of oncogenes and tumor suppressor genes. Results from these studies may provide the rationale for the design of future novel clinical trials. The evaluation of these preclinical models may lead to predictive value related to patient response to therapy as well as clinical trials. With consent, these models may be shared with other investigators internal or external to Mayo Clinic.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Patient is a good medical candidate for a standard of care or research biopsy or surgical procedure to obtain tissue

Exclusion Criteria:

* Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
* Institutionalized or incarcerated patients
* Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use
* Biopsy must not be considered more than minimal risk to the patient.
* Have a contraindication to percutaneous biopsy including:

  1. Significant coagulopathy that cannot be adequately corrected.
  2. Severely compromised cardiopulmonary function or hemodynamic instability.
  3. Lack of a safe pathway to the lesion per the interventional radiologist.
  4. Inability of the patient to cooperate with, or to be positioned for, the procedure.
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis

To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF.


Eligibility Criteria:
Inclusion Criteria

Patient must have the following:

* AIDS as defined by CDC criteria.
* Retinitis as diagnosed by the study ophthalmologist.
* Performance status 0, 1, or 2.
* Ability to give informed consent and suitability of intravenous access for scheduled blood tests.
* Patient may have Kaposi's sarcoma or basal skin cancer.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Active acute infection requiring treatment.
* Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
* Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.

Patients with the following are excluded:

* Active acute infection requiring treatment.
* Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
* Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.

Prior Medication:

Excluded:

* Granulocyte macrophage colony-stimulating factor (GM-CSF).
* Colony stimulating factor.
* Interleukin 3.
* Excluded within 7 days of study entry:
* Zidovudine (AZT).
* Trimethoprim / sulfamethoxazole (TMP / SMX).
* Pyrimethamine.
* Excluded within 30 days of study entry:
* Biologic response modifiers.
* Cytotoxic agents.
* Investigational agents.

Prior Treatment:

Excluded:

* Radiation therapy.

Required within 1 week of study entry:

* One or more doses of ganciclovir.
Influence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol

Effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but also on technical properties of the inhalers. Different inhalers have different internal resistances and therefore it is expected that patients with limited airflow may have different exposure rates of drugs delivered from different devices


Eligibility Criteria:
Inclusion criteria:

* Asthma Reversibility \>15% and 200 ml in total FEV1 \<85% of normal

Exclusion criteria:

* Smoking history \>20 pack years Treatment with ICS \>500μg Fluticasone or aquivalent in the last 4 weeks Asthma exacerbation in the last 4 weeks
Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery

This is observational study. The investigator will measure optic nerve sheath diameter by ultrasound on the eye after cesarean section under spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cesarean section under spinal anesthesia

Exclusion Criteria:

* Patients who did not agree to participate in the study
* Patients has ophthalmic diseases
* Patients has previous history of ophthalmic surgery.
* Patients has neurological disorders.
* Patients has history of head surgery.
Pediatric Postoperative Analgesia Herniorrhaphy Study

This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.


Eligibility Criteria:
Inclusion Criteria:

* Is scheduled to undergo a unilateral open inguinal herniorrhaphy with or without mesh under general anesthesia.
* Has an American Society of Anesthesiologists Physical Status of I, II, or III.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
* Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Has taken meloxicam within least 10 days prior to the scheduled surgery.
* Has been administered bupivacaine within 5 days prior to the scheduled surgery.
* Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study.
* Previously participated in an HTX-011 study.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
* Has a body mass index (BMI) \>35 kg/m2.

In addition to the preceding exclusion criteria 1 through 14, subjects to be enrolled in Cohort 1 Part B, Cohort 2 Part B, or Cohort 3 who meet any of the following criteria prior to randomization will be excluded from the study:

* Has had a prior ipsilateral inguinal herniorrhaphy.
* Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
* Has taken long-acting opioids within 3 days prior to the scheduled surgery.
* Has taken any opioids within 48 hours prior to the scheduled surgery.
* Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control.
* Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
* Has undergone 3 or more surgeries within 12 months.
Eculizumab in Primary MPGN

Membranoproliferative glomerulonephritis (MPGN) is the third or fourth leading cause of end stage renal disease among the primary glomerulonephritis. Hyperactivation of the alternative complement pathway and familial forms for all types of MPGN have been reported suggesting that genetic abnormalities may play a predisposing role to the disease. In recent case reports Eculizumab, a monoclonal antibody that binds to C5 to prevent formation of the membrane attack complex ,is a safe and effective therapy.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven primary MPGN
* Creatinine clearance \>20 ml/min per 1.73m2
* 24-hour proteinuria persistently exceeding 3,5g in adults or exceeding 40mg/h/m2 in children (or exceeding 2mg protein/mg creatinine in children spot urine samples)
* Persistently low C3 levels in at least two consecutive evaluations
* Persistently high sC5b9 levels (\>1000 ng/ml) in at least two previous consecutive evaluations
* Written informed consent (by parents or tutors if underage)

Exclusion Criteria:

* Age ≥75 years
* Secondary MPGN (evidence of infection, immunological disease including vasculitis, systemic diseases and proliferative disorders)
* Evidence at kidney biopsy evaluation of severe chronic histological changes that very unlikely could benefit of eculizumab therapy
* Concomitant steroid or immunosuppressive therapy for immuno-mediated disease
* Pregnancy or lactating
* Childbearing potential without effective contraception
* Any clinically relevant condition that might affect completion of the study participation and/or confound study results
* Inability to understand the potential risks and benefits of the study
* Legal incapacity
Bufei Recipe Reduces the Incidence Rate of COPD

Establish early TCM prevention and treatment program to reduce the incidence rate of COPD.

Taking PRISM patients with impaired lung function at the early stage of COPD retention ratio as the research object, and aiming at the key problems such as the lack of prevention and treatment plan, a two-year randomized double-blind placebo controlled clinical study of Bufei Fang was carried out to establish the early stage TCM prevention and treatment plan to reduce the incidence rate of COPD.

Eligibility Criteria:
Inclusion Criteria:

1. Risk factors for chronic obstructive pulmonary disease. Having one item from a, b, and c (risk factors will be further optimized based on the screening results of high-risk populations):

   1. smoking history (including previous and current smokers);
   2. 1 year or more of exposure to dust or chemical toxins;
   3. Indoor air pollution for 1 year or more (use of contaminated fuels, passive smoking, exposure) Oil fumes, etc.
2. Have a history of chronic bronchitis and/or emphysema, and have one of the following chronic respiratory symptoms:

   1. Cough (more than 3 months per year, continuous for 2 years or more);
   2. Coughing phlegm (more than 3 months per year, continuous for 2 years or more);
   3. Difficulty breathing (more than 3 months per year, continuous for 2 years or more).
3. The lung function test meets the following criteria: forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≥ 70% and FEV1 accounting for%\<80% of the expected value.
4. Meets the diagnostic criteria for lung qi deficiency syndrome.
5. Age range from 18 to 80 years old.
6. Voluntarily participate in the study and sign an informed consent form.

Exclusion Criteria:

* Pregnant and planned pregnancy, lactating women.
* Dementia and various mental illness patients.
* Other diseases with chronic cough, sputum production, or difficulty breathing.
* Merge tumors.
* Merge severe cardiovascular and cerebrovascular diseases.
* Concomitant severe liver and kidney diseases.
* Participants in clinical trials of other drugs.
* Allergies to intervention drugs.
(Cost)effectiveness of the Intervention 'Gezond En Goed Met Elkaar'

The goal of this intervention study is to learn if the intervention can increase positive health and health literacy in people with limited health literacy. The main questions it aims to answer are:

* Does participating in the intervention 'Gezond en goed met elkaar' increase participant's positive health?
* Does participating in the intervention 'Gezond en goed met elkaar' improve health literacy?

Researchers will compare people who participate in the intervention with people who haven't participated in the intervention yet.

Participants will:

* participate in the intervention (3 months)
* fill out questionnaires every 3 months


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older

Exclusion Criteria:

* analfabetism
* insufficient language level of Dutch to be able to participate in the intervention
Study of the Role of Genetic Modifiers in Hemoglobinopathies

This study will investigate the role of genetic modifiers in hemoglobinopathies through a large-scale, multi-ethnic genome-wide association study (GWAS).

Hemoglobinopathies, including sickle cell disease (SCD) and beta-thalassemia, are prevalent diseases with variable clinical manifestation and severity that are thought to be governed, in part, by genetic modifiers. Despite the identification and characterization of a few putative genetic modifiers by previous studies, these are as yet insufficient to guide treatment recommendations or risk-stratify patients reliably. Also, it is expected that many additional genetic variants exist that can modify disease and its severity. This large-scale genome-wide association study (GWAS) will utilize SNP chips to investigate the genetic profile of individuals with hemoglobinopathies, thereby addressing the challenges of previous studies related to small sample sizes and low statistical power, while promoting the participation of diverse populations worldwide. The study aims to i) discover new genetic modifiers of hemoglobinopathies, ii) validate previously reported genetic modifiers, iii) pool and analyze existing genomic data, iv) standardize phenotypic descriptions, v) develop a research resource of disease-specific data generated in INHERENT, including genomic, phenotypic, and functional data, and vi) develop risk scores that can be used for patient stratification.

The main endpoints include:

1. Worldwide demography, including numbers of patients, main genotypes, and overall disease severity/burden in participating centres
2. Genetic modifiers affecting clinical or laboratory phenotypes of hemoglobinopathies, including

   1. overall survival in SCD and/or thalassemia,
   2. stroke and/or decreased neurocognitive function in SCD and/or thalassemia,
   3. renal impairment in SCD and/or thalassemia,
   4. leg ulcers in SCD,
   5. priapism in SCD,
   6. mild or severe acute pain and/or chronic pain syndromes in SCD,
   7. pulmonary hypertension in SCD and/or thalassemia,
   8. hyperhemolysis in SCD and/or thalassemia,
   9. fetal hemoglobin levels,
   10. degree of ineffective erythropoiesis,
   11. hepatic fibrosis/cirrhosis and/or cardiac siderosis,
3. Genetic modifiers affecting response to treatment, including

   1. response to hydroxyurea,
   2. response to iron chelation treatment,
   3. response to emerging therapeutic agents

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of an inherited hemoglobinopathy, including sickle cell disease (SCD), β-thalassemia, and α-thalassemia; all genotypes will be considered.
* Age ≥ 2 years old at the time of the collection of the phenotypic data.
* There will be no limits on study participants in terms of gender, ethnicity, morbidities.

Exclusion Criteria:

* Patients treated with stem cell transplantation or genetic therapy.
* Age \< 2 years old at the time of the collection of the phenotypic data.
* Patient or legal representative for minors unwilling or unable to give consent.
Linkage to Care - Part I

This first phase of a two-phase study involves three components:

1. Review of existing linkage-to-care protocols and sources of referrals for care;
2. Semi-structured telephone or face-to-face interviews with a minimum of two personnel per site who are associated with linkage to medical care. (Preference will be given to personnel with direct experience in linkage to care); and
3. Structured observations of referral sessions.


Eligibility Criteria:
Inclusion Criteria:

* Component 1: Documents identified by clinical site personnel as pertaining to post-test counseling, linkage to care, or standard operating procedures addressing post-test counseling and linkage to care.
* Component 2: Persons employed by one of the AMTUs or an identified linkage-to-care partner and work as clinical staff or a case-manager or is a person familiar to linkage to care; or persons involved in posttest counseling and linkage-to-care processes. Clinical staff and case managers are chosen based on direct experience in the assistance of HIV seropositive youth obtaining medical care. This definition includes, but is not limited to, physicians, nurses, psychologists, social workers, and case managers (who may have diverse professional backgrounds).
* Component 3: All AMTU sites will be included.

Exclusion Criteria:

* Component 1: No a priori exclusions.
* Component 2: No a priori exclusions.
* Component 3: No a priori exclusions.
Post-Market Clinical Follow Up Study to Collect Additional Data and Imaging

This is a prospective, open label, multi-center clinical study to collect additional data and imaging for the ViaSure device.The intended use of the ViaSure device used in this study is to assess the usability and tissue response to shock wave treatment.

Up to 50 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments with the study device. Follow up visits may occur 30 and 90 days post last treatment visit.

Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female 18 - 65 years of age.
* Willing to undergo treatments with the SoftWave device.
* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria:

* Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
* The subject has a pacemaker or implantable defibrillator.
* The subject has a severe coagulation disorder.
* The subject has open epiphyseal plates.
* The subject has recently had a steroid injection.
* The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study.
* The subject has any condition or is in a situation which, in the Investigator's opinion, may put the subject at significant risk, may