cyrilzakka/clinical-trials huggingface dataset:
Cross-over Study on Effect of Lipid Lowering by Acipimox on Cardiac and Skeletal Muscle Mitochondrial Function

Accumulation of lipid in skeletal and cardiac muscle has been associated with insulin resistance and diabetic cardiomyopathy. In skeletal muscle, lipotoxic damage has been suggested to lead to dysfunction of mitochondria. It remains unknown whether lipotoxicity leads to mitochondrial dysfunction in heart as well, and if so, whether this also leads to cardiomyopathy (failure of the heart). Although it has been shown that lipid lowering agents can improve insulin sensitivity, the effect of lowering free fatty acids on cardiac and skeletal muscle mitochondrial function remains unknown. In this study the investigators want to investigate whether lowering cardiac and muscular lipid content will improve mitochondrial and cellular function in type 2 diabetic patients.

To this end, type 2 diabetic patients and body mass index (BMI)-matched controls will be included in a blinded cross-over design, in which subjects will receive a lipid lowering agent (Acipimox) or placebo for 2 weeks in random order. During treatment, diabetes medication will be stopped. Baseline measurements will be performed prior to the study and after each treatment to assess cardiac and muscular lipid accumulation, cardiac function, mitochondrial function and insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Male or postmenopausal females
* Age 40-70 years
* Obese (BMI \> 30 kg/m2), non-insulin dependent type 2 diabetic patients and BMI matched control subjects without diabetes.
* Generally healthy with specifically no known cardiovascular disease, dyslipidemia, or gastric ulcers (contra-ind. of Acipimox), which can affect the study parameters.
* Must be on sulphonylurea(SU)- derivate or metformin therapy for at least six months with a constant dose for at least two months, or on dietary treatment for at least six months
* Well-controlled diabetes: HbA1c\<8%.
* Control subjects must have a plasma glucose lower than 6,1 mmol/L.
* Stable dietary habits (no weight loss/gain \> 3 kg in the last 6 months)

Exclusion Criteria:

* Known cardiovascular disease, dyslipidemia, hepatic or renal failure and gastric ulcers.
* Insulin dependent Diabetic patients.
* Use of lipid lowering agents, except from Statins, as these do not affect triglycerides levels (with exception to Lipitor).
* Use of Thiazolidines (glitazone/rosiglitazone/pioglitazone/troglitazone)
* Use of anti-coagulants (not thrombocyte-aggregation inhibitors)
* Aberrant ECG (with signs of ischemia or cardiac failure or arrythmia's)
* Weight gain/loss \> 3 kg in the last 6 months.
* Hb \< 7,3 in women, and \< 7,8 in men.
* Contraindications for MRI scans:

  * Electronic implants such as pacemakers or neurostimulator
  * Iron-containing corpora aliena in eyes or brain
  * Some hearing aids and artificial (heart) valves which are contraindicated for MRS
  * Claustrophobia
* Subjects, who do not want to be informed about unexpected medical findings, or do not wish that their physician is informed, cannot participate in the study.
Nitric Oxide Therapy for Acute Chest Syndrome in Sickle Cell Disease Children

Acute chest syndrome is a severe sickle cell disease complication in children requiring blood transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a potent vasodilator that could reverse pulmonary vascular occlusion and restore normal oxygenation. The randomized trial will test that hypothesis.

Acute chest syndrome is a severe sickle cell disease complication in children requiring blood transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a potent vasodilator that could reverse pulmonary vascular occlusion and restore normal oxygenation. The randomized trial will test that hypothesis in a prospective randomized double-blind placebo controlled study. 50 children in two years will be included: 25 in each arm.

Eligibility Criteria:
Inclusion Criteria:

* child between 1 and 18 years old
* Sickle cell anemia or equivalent (sickle beta 0 thalassemia)whoe weight is between 10kg and 65kg
* presenting acute chest syndrome as defined a new radiological infiltrate with tachypnea, respiratory discomfort, cough, chest wall pain and fever more than 38.5°C
* hypoxaemia with transcutaneous oxygen saturation equal or less than 92%
* informed consent signed by parents and approved by the child able to express his consent
* insured by the National social security system or by the universal medical insurance
* previous medical physical examination

Exclusion Criteria:

* respiratory distress with hypoxaemia with transcutaneous oxygen saturation equal or less than 92% under more than 5l/min of oxygen or 40% oxygen inhaled, hypercapnia signs 'sweating, altered consciousness, paCO2 more than 60mmHg) with need of emergency exchange transfusion and/or tracheal intubation with mechanical ventilation
* Isolated acute asthmatic crisis
* stroke or priapism with emergency acute transfusion needed
* acute anemia with hemoglobin drop of more than 20% as compared to steady state hemoglobin
* chronic long term transfusion therapy
* nitric oxyde hypersensitivity
* patients with right-left extra-pulmonary cardiac shunt
* patient previously included in the protocol
* patient participating in another interventional protocol
* pregnancy or breast feeding
Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients

The purpose of this study is to measure the immune response in 18-40 year old IBD patients after receiving the hepatitis A vaccine.

The spread of hepatitis A has prompted the need for vaccination against this virus. It is uncertain that IBD patients can achieve a truly protective response after vaccination. The efficacy and safety of hepatitis A vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against hepatitis A in patients with IBD.

Eligibility Criteria:
Inclusion Criteria:

1. Patients suffering from inflammatory bowel disease: Crohn's disease/Ulcerative colitis
2. Age 18-40
3. Willing to provide informed consent

Exclusion Criteria:

1. Have history of vaccination to hepatitis A
2. Have other autoimmune disease
3. Have any malignancy
4. Have acute infectious disease
5. Unwilling to provide consent
Dealcoholized Muscadine Wine and Skin Health in Women

The objective of this clinical trial is to determine the activity of dealcoholized muscadine wine to alleviate oxidative stress, inflammation, skin photoaging, and alter gut microbiome in women 40-67 years of age. The investigators hypothesize that dealcoholized muscadine wine daily for 42 days will significantly alleviate oxidative stress, inflammation, skin photoaging, and alter the gut microbiome in women compared to drinking sugar water.

Aging of the skin is characterized by wrinkling, sagging, and laxity. About 80% of facial skin aging is classified as extrinsic, or photoaging because it results from exposure to UV light of the sun that causes oxidative stress The remaining 20% of facial aging is the intrinsic type which is partially caused by the accumulation of proteins that are modified by reactive carbonyls in a reaction known as protein glycation. Aging also shifts the composition of the gut microbiome in at least 35 genera towards an unhealthy state of dysbiosis.

Previous studies showed that muscadine polyphenols inhibited protein glycation under a simulated physiological condition. Additional experiments using cell culture and mice showed that dealcoholized muscadine wine alleviated inflammation and protected against dysbiosis in the gut. The objective of this research is to confirm the health benefits of muscadine wine polyphenols in a clinical trial. The investigators hypothesize that dealcoholized muscadine wine consumption in women 40-65 years old will alleviate skin photoaging and skin conditions by decreasing oxidative stress and inflammation. It is also expected to improve the composition of the gut microbiome.

Eligibility Criteria:
Inclusion Criteria:

* Healthy,
* BMI 20.0-29.9
* Fitzpatrick skin type 2 and 3.

Exclusion Criteria:

* pregnancy
* breast-feeding
* smoking
* alcohol use
* history of skin cancer
* intake of medication that might influence the outcome of the study
* sunbathing or the use of tanning bed
* intake of vitamin/mineral supplements
Intervention in Single Thyroid Nodule.

Thyroid nodules are common clinical problem. The incidence is 2-4 per 100,000 people per year, being more common in women and the elderly. thyroid nodule is a "discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. Most thyroid nodules are asymptomatic, may present as neck swelling

Thyroid nodular disease comprises of a wide range of disorders. Benign forms such as colloid nodules,cysts and thyroiditis are more comman than benign follicular neoplasms and thyroid carcinomas. Incidence of malignancy ranges from 10% to 30% in solitary thyroid nodule(STN).Studies have shown that the occurrence of malignancy is higher in case of solitary thyroid nodule compared to multinodular goitres. Preoperative evaluation of thyroid nodules is important in distinguishing between benign and malignant thyroid nodules and also in treatment to avoid unnecessary extensive surgery and its complications. Fine needle aspiration biopsy (FNAB) is the most common method of examining solitary thyroid nodules today.Total thyroidectomy and lobectomy remain the main primary surgical interventions for single thyroid nodule. There is debat between total thyroidectomy and hemithyroidectomy for patients with single thyroid nodule. our study is for comparing between total thyroidectomy and hemi thyroidectomy in single thyroid nodule

Eligibility Criteria:
Inclusion Criteria:

1. Age from 20 to 60 years.
2. patients with single thyroid lesion
3. Fit for surgery

Exclusion Criteria:

1. patients with age less than 20 years and more than 60 years.
2. patients with multiple thyroid lesions.
3. patients with advanced and metastatic malignancy.
4. Unfit for surgery
Gastrointestinal Toleration of Inulin Products

The intake of inulin products has been linked to multiple health benefits which has lead to inulin fortification in food products.

The investigators hypothesis that doses of up to 10 grams of inulin products should be well tolerated and not result in a significant increase in gastrointestinal symptoms.

0, 5, and 10 grams of inulin

Eligibility Criteria:
Inclusion Criteria:

* english speaking
* healthy men and women
* 18 and 60 years of age
* non-smoking
* non-dieting
* BMI less than 30
* standard diet consisting of no more than 15 grams fiber
* not taking medications

Exclusion Criteria:

* BMI more than 30
* CVD
* Diabetes Mellitus
* cancer in prior 5 years
* renal or hepatic disease
* bacterial infection in past 2 weeks
* more than 5 kg weight loss in past 3 months
* history of drug or alcohol abuse in past 6 months
* use of weight loss, lipid-lowering, anti-hypertensive, or anti- inflammatory medications
* concurrent or recent intervention study participation
* consumption of laxatives
* history of gastrointestinal disorders
* food allergies
* pregnant or lactating women
Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment

The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity by the agents Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis.

Cervical dentin hypersensitivity is a painful condition and is a clinical challenge due to different treatment strategies available. The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity. A hundred forty teeth of healthy patients of both sexes were selected. Visual Analog Scale was used pain (VAS) to measure the intensity of the patient's pain. The teeth will be randomly divided into 7 different groups according to the desensitization treatment under study: Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* presence of dentin exposure lesions with clinical diagnosis of moderate or severe tooth sensitivity
* good oral hygiene.

Exclusion Criteria:

* cavities,
* presence of periodontal disease and or parafunctional habits,
* cracks or enamel fractures,
* extensive or unsatisfactory restorations,
* recent restorations involving the labial surface,
* dentures,
* orthodontics.
Endoscopically Placed Lumen-Apposing Metal Stents for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease

This is a single-center prospective pilot study in patients with symptomatic partially obstructing intestinal strictures without severe active inflammation or penetrating complications, evaluating the use of LAMS with respect to symptom and quality of life improvement and the development of stent-related complications.

This will be a prospective case series study in \~20 IBD patients with symptomatic partially-obstructing intestinal strictures \&amp;lt; 6 cm in length without severe active inflammation (large or deep ulcers at distal entrance or moderate-severe friability or severe inflammatory changes in the stricture on radiographic imaging, at the discretion of the referring IBD physician or treating therapeutic endoscopist) or penetrating complications (pre-stenotic fistula or intra-abdominal phlegmon or abscess), evaluating the use of LAMS with respect to symptom and quality of life improvement and the development of stent-related complications.

The objective of this project is to evaluate the safety and efficacy of LAMS for the treatment of short segment, symptomatic, IBD-related strictures.

The hope is that positive results from this pilot study will provide sufficient rationale to trigger a larger scale multicenter study to fully assess the efficacy of endoscopic stenting for IBD-related strictures.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Established Diagnosis of inflammatory bowel disease
* Symptomatic, single, fibrostenotic or anastomotic stricture \&lt;6 cm in length without severe active inflammation, pre-stenotic intestinal fistula or penetrating complication, and within reach of the adult colonoscope (colon or terminal ileum)
* Ability to accurately gauge stricture length with imaging and safely deploy the stent using conventional fluoroscopic techniques
* Able to provide informed consent

Exclusion Criteria:

* More than one intestinal stricture
* Stricture out of reach of standard adult colonoscope
* High-grade stricture (complete or near complete bowel obstruction
* Severe active inflammation in the stricture or associated penetrating complication, including fistula, inflammatory phlegmon or abscess
* Contraindications for endoscopic therapy, including:
* Complete Bowel obstruction
* Severe cardiorespiratory comorbidity
* Unable to tolerate sedation or anesthesia
* Non-reversible coagulopathy
A Study of Robotic Assisted Laparoscopic Sacral Colpopexy Using Alyte Mesh

Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcomes. This advanced procedure is offered at Morristown Memorial. THis protocol will review the one year outcome of patients who underwent this pocedure using a polypropylene mesh. These outcomes will incude anatomical and quality of life measures.


Eligibility Criteria:
Inclusion Criteria:

* Any patient receiving Robotic assisted laparoscopic sacral copopexy with polypropylene mesh
* \>21 y.o

Exclusion Criteria:

* Graft material other than polypropylene mesh
* Enrollment in another study
Observational Study on the Use of Akynzeo® in Patients Receiving HEC

This Canadian, multi-centre, prospective, observational real-world study is designed to collect patient-reported outcome data on the use of Akynzeo® (netupitant/palonosetron) for the prevention of nausea and vomiting in oncology patients receiving highly emetogenic chemotherapy (HEC).

The study will assess quality of life using the Functional Living Index of Emesis (FLIE) questionnaire and generate Real World Evidence in support of existing clinical trial data, including effectiveness and safety of Akynzeo® in the real world setting for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC).

Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Patient scheduled to receive a highly emetogenic chemotherapy (HEC).
2. Patient scheduled to receive antiemetic prevention with Akynzeo® according to the approved Canadian Product Monograph as deemed medically necessary by the participating physician independently from this study.
3. Age ≥ 18 years.
4. Women of childbearing potential must use effective contraception during therapy and up to one month after treatment with Akynzeo®.
5. Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent prior to or at the screening visit.
6. Patient is able and willing to comply with the study protocol for the entire length of the study and will follow all study requirements, procedures and complete all visits as required.
7. Patient is participating in another clinical trial where antiemetic treatment is not pre-specified by the study protocol.

Exclusion Criteria:

1. Women of child bearing potential who are pregnant, planning on becoming pregnant or breast feeding.
2. Hypersensitivity to active substances, excipients or other ingredients of Akynzeo®.
3. Concomitant use of pimozide, terfenadine, astemizole, or cisapride.
4. Patient currently enrolled in another clinical trial where antiemetic treatment is pre-specified by the study protocol.
A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC

A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or metastatic non-small cell lung cancer (NSCLC).

Phase 1 Dose Escalation: To evaluate the overall safety profile, efficacy of TPX-0131 in pretreated subjects with ALK+ advanced or metastatic NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 (or as required by local regulation).
* Histological or cytological confirmation of advanced/metastatic ALK+ NSCLC.
* Pretreated with up to three prior lines of an ALK TKI treatment, including at least one prior line of a second or third-generation ALK TKI (alectinib, brigatinib, ensartinib, or lorlatinib) in Phase 1.
* ECOG performance status ≤ 1.
* Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors \[RECIST v1.1\] criteria).
* Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.
* Adequate organ function.

Exclusion Criteria:

* Major surgery within four weeks of the start of TPX-0131 treatment.
* Clinically significant cardiovascular disease
* Any of the following cardiac criteria:

  * Mean resting corrected QT interval (QTc) \> 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events
  * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
* Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
* Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
* Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
* Subjects with current or anticipated need for drugs that are sensitive CYP2C9 substrates with narrow therapeutic indices.
A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated

* CpG has the potential to stimulate the immune system
* this study will evaluate the safety of CpG given sub-q or IV
* purpose is to measure biological changes in CLL cells after receiving CpG


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL
* CLL previously treated
* Hemoglobin \>/= 10
* Platelets \>/= 50,000
* Neutrophils \>= 1,000 -

Exclusion Criteria:

* patients with brain mets
* patients with autoimmune disease
* patients on corticosteroids or immunosuppressants
* patients with uncontrolled intercurrent illness
* pregnant women
* HIV patients receiving combination anti-retroviral therapy
Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.

For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).

The objectives of the study are to develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms.

Patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).

Patients will then be allocated to study drug in a double-blind, randomized, double-dummy, placebo-controlled fashion.

Patients will be administered an IM injection of study drug at Week 0, 2, 26 and 28 and will be followed up to Week 52.

Then, in an open label fashion, patients will be administered an IM injection of study drug at Week 52, 54, 78 and 80 and will be followed up to Week 90.

Eligibility Criteria:
Inclusion Criteria:

* Benign Prostatic Hyperplasia, based on medical history
* Voiding symptoms

Exclusion Criteria:

* Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder
* Major organ dysfunction
* Eczema (atopic dermatitis) treated during the last 6 months
* Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior randomization or with α blockers or saw palmetto within the last 6 weeks prior to randomization
* Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy
* History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months