cyrilzakka/clinical-trials huggingface dataset:
Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel

This randomized pilot trial studies how well minocycline hydrochloride works in reducing chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer undergoing treatment with paclitaxel. Drugs used in chemotherapy, such as paclitaxel, may cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and toes. Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the quality of life in breast cancer patients.

PRIMARY OBJECTIVES:

I. To estimate whether minocycline hydrochloride (minocycline) can alleviate paclitaxel-induced peripheral neuropathy.

II. To estimate whether minocycline can alleviate paclitaxel acute pain syndrome (P-APS).

III. To examine the possible relative toxicities related to minocycline therapy in this study situation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive minocycline hydrochloride orally (PO) twice daily (BID) on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of the study, patients are followed up every month for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Ability to complete questionnaires by themselves or with assistance
* Planned paclitaxel at a dose of 80 mg/m2 IV given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors)
* Life expectancy \> 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Negative pregnancy test (serum or urine) done =\< 7 days prior to registration, for women of childbearing potential only (determined per clinician discretion)

Exclusion Criteria:

* Any of the following:

  * Pregnant women
  * Nursing women
  * Men or women of childbearing potential who are unwilling to employ adequate contraception
* Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
* History of allergic or other adverse reactions to minocycline
* Prior exposure to neurotoxic chemotherapy
* Diagnosis of fibromyalgia
* Current or planned use of methoxyflurane, oral contraceptives, isotretinoin, penicillin, or ergot alkaloids
* History of allergic or other adverse reactions to tetracycline
The Role of S-nitrosohemoglobin in Regulating Systemic Blood Flow During Hypoxia and Normoxia

Nitric oxide is believed to contribute to regulation of blood flow by its selective binding to circulating hemoglobin (forming S-nitrosohemoglobin, SNO-Hb) and release in a PO2-dependent manner. This study is designed to test that hypothesis by measuring the effect of hypoxia and exercise on forearm blood flow before and after depletion of SNO-Hb using oral N-acetylcysteine.

NO has been shown to associate with erythrocytes in the form of SNO-Hb and can deliver vasomotor changes as erythrocytes pass through a physiologic O2 gradient. The aim of this study is to transiently deplete circulating SNO-Hb levels to prove that these levels are directly linked with the normal physiological vasodilation that occurs in response to brief hypoxia that occurs in moderate exercise. This study will be performed on healthy volunteers especially with no predisposing cardiovascular or respiratory conditions that may change their vasomotor response to hypoxia. Systemic blood flow will be approximated using non-invasive forearm venous occlusion plethysmography which will be performed initial to gather baseline data. The participants will then undergo 4 days of 600 mg BID oral N-acetylcysteine (NAC) solution treatment which acts as a bait reactant for NO groups bound to hemoglobin (SNO-Hb) and will then undergo retesting with forearm plethysmography. At the time of both blood flow measurements, arterial blood samples will also be gathered via an arterial catheter inserted on each of two testing days to determine SNO-Hb levels. Statistical analysis will include measuring the blunting of the hypoxia response and SNO-Hb levels using baseline testing as a self-control for each participant. Large scale human placebo-controlled trials with high-dose oral NAC (up to 8000 mg/day) for periods up to 12 months have shown no clinically significant adverse reactions, much less than in the proposed study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Pregnancy
* smoking
* pulmonary disease
* cardiovascular disease
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women

Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.

Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 18-44 years
* Gestational age ≤ 25 weeks

Exclusion Criteria:

* Male
* Under 18 years old
* Over 44 years old
* Gestational age \> 25 weeks
REST: Reducing End-of-Life Symptoms With Touch

The purpose of this study is to determine whether massage therapy is effective in reducing pain and distress and improving quality of life among cancer patients at life's end.

Relieving physical and emotional symptoms is a key component of end-of-life care. Despite care, terminally ill patients are still significantly burdened by unrelieved symptoms. Therapies that have potential to alleviate these symptoms deserve thorough investigation.

This study will last 3 weeks. Participants in this study will be randomly assigned to receive six sessions of either moving or nonmoving touch therapy, in addition to usual hospice care, for 2 weeks. Moving touch therapy consists of massage therapy in which a trained therapist continually touches a person's body. The nonmoving touch therapy will be conducted by volunteers who have no previous experience in massage. Participants in this group will have a volunteer rub specific body parts for 3-minute intervals. Because current evidence suggests that thoughts of healing may influence the effectiveness of touch therapy, volunteers in the nonmoving therapy group will distract their minds to avoid thinking of healing processes. In both groups, the person administering the touch therapy will note all interruptions during a session, including talk, music, and television. Interviews about medication use, pain, and quality of life will be used to assess participants; these interviews will be conducted at study start, immediately before and after each therapy session, and at Weeks 1, 2, and 3.

Eligibility Criteria:
Inclusion Criteria:

* Advanced cancer, with at least moderate pain 1 week prior to study entry
* Life expectancy of at least 3 weeks
* Able to speak English

Exclusion Criteria:

* Massage therapy within 1 month prior to study entry
* Current use of anticoagulants
* Platelet count less than 10,000
* Unstable spine that would interfere with touch therapy
The Effect of Amiloride and Spironolactone in Patients With Hypertension

The investigators wish to investigate the potential effects of potassium. In this study we will examine patients with hypertension and increase their potassium-levels using Amiloride and Spironolactone.

The investigators will examine the changes in the cardiovascular system using a Sphygmocor-scanner.

Purpose of the study is to examine the effect of amilorid and spironolacton on

1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
2. Pulsewavevelocity, augmentation index and centralt bloodpressure,
3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
4. Ambulatory blood pressure

Eligibility Criteria:
Inclusion Criteria:

* Hypertension
* Age 45-70
* BMI: 18,5-30

Exclusion Criteria:

* Other diseases
* Drug or alcohol abuse
* Abnormal findings in the screening procedure
Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.

The purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female 21 years of age or older
* Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-25 days between surgeries.
* Willing and able to administer eye drops and record the times the drops were instilled
* Understand and are willing to sign the Informed Consent form
* Willing to complete the entire course of the study.

Exclusion Criteria:

* Use of an eye medication or drops within 48 hours of the scheduled cataract surgery, other than the study medication or procedural solution required for surgery.
* Known sensitivity to any of the ingredients in the study medications or similar medications.
* Scheduled for 2nd eye cataract surgery earlier than 6 days or longer than 25 days apart.
* Corneal edema in either eye.
* Need for regional or general anesthesia during surgery.
* Complicated cataract surgery, including use of iris hooks or iris stretchers.
* Sight better than 20/100 in only one eye.
* A history of previous intraocular surgery in either eye.
* A history of uveitis, iritis, or intraocular inflammation.
* Macular pathology of the retina.
* Presence of glaucoma.
* Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
* History of steroid-related intraocular pressure (IOP) rise in the study eye.
* Lack of an intact corneal epithelium.
* Pupils that do not dilate to more than 5 mm prior to surgery or you require mechanical stretching of your pupil.
* Diabetes mellitus.
* Required use of a systemic steroidal or non-steroidal anti-inflammatory during the study period.
* Doctor has determined the presence of a condition (i.e., UNCONTROLLED systemic disease) or a situation that may put the subject at significant risk, confound the study results or may interfere significantly with your participation in the study.
* Females, who are pregnant, nursing an infant or planning a pregnancy.
* Currently involved in another investigational study or have participated in one within the 30 days prior to entering this study.
* Unable or unwilling to give signed informed consent prior to participation in any study-related procedures.
Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure

The goal of this clinical trial is to learn if mesenchymal stem cells in blood purification works to treat liver failure in adults. It will also learn about the safety and effectiveness of mesenchymal stem cells in blood purification. The main questions it aims to answer are:1.Does mesenchymal stem cells in blood purification improve the condition of patients with liver failure? 2.What medical problems do participants have when taking mesenchymal stem cells in blood purification? Participants will receive routine medical treatment and blood purification treatment with mesenchymal stem cells.These cells work outside the body and do not enter the body. We will: 1.Collect samples from participants such as blood, Urine and feces. 2.record post-treatment outcomes such as survival rate at 4 weeks after treatment, conversion rate to liver transplantation, Inflammatory, survival rate at 7days, 14days, 8 weeks and 12 weeks after treatment, and liver disease indicators(prothrombin time activity percentage, lactic aicd, blood ammonia, α-fetoprotein, ferritin).


Eligibility Criteria:
Inclusion Criteria:

1. Age range from 18 to 65 years old;
2. Patients with acute liver failure in the early and intermediate stages caused by various reasons;
3. Total bilirubin (TBil) ≥ 171μmol/L or an increase of ≥ 17.1μmol/L per day;
4. Prothrombin activity (PTA) between 20% and 40% (or INR between 1.5 and 2.6);
5. No hepatic encephalopathy or encephalopathy below grade II (including grade II);
6. Elevated inflammatory markers (IL-6 / TNF-α / CRP, etc.);
7. The subjects are able to communicate well with the researchers and can complete the study in accordance with the study regulations;
8. The subjects must be informed of this study and voluntarily sign a written informed consent form before the experiment.

Exclusion Criteria:

1. Patients with severe active bleeding or diffuse intravascular coagulation;
2. Patients with a high degree of allergy to blood products or drugs used during treatment, such as plasma, heparin, and protamine;
3. Patients with circulatory failure;
4. Patients with a MELD score \> 30;
5. Patients with other severe heart diseases, lung diseases, blood diseases, autoimmune diseases, or diabetes;
6. Subjects who may be unable to complete this study for other reasons or who the researchers believe should not be included.
Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder

The purpose of this observational study is to compare the administration of standard of care Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion time and infusion related reactions. Patient satisfaction, number of actions taken by the nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.

Given the growing number of patient contacts at our day-care center, there is a continuous search to further improve the flow and to shorten the time spent per patient at the day-care center, without loss of quality in care.

In order to achieve this goal, this study wants to compare the administration of Multigam IV 5% and Multigam IV 10%. Multigam 5% and Multigam 10% are immunoglobulin solutions that are administered to strengthen the body's natural defense system (immune system). In case of recurrent infections, patients with an immunodeficiency secondary to a hematologic disorder can be treated with immunoglobulin substitution therapy. Patients can receive Multigam IV 5% and Multigam IV 10% in daily clinical practice and will receive both formulations in the same manner and intensity, meaning their use is not limited to this study.

For this observational study, patients with an immunodeficiency secondary to a hematologic disorder will be evaluated for inclusion. Patient characteristics, infusion time, time spent at the day-care center, adverse events and number of actions taken by the nursing staff will be evaluated for Multigam 5% administration. After 3-4 weeks, patients will return for Multigam 10% administration and an identical evaluation will take place along with a questionnaire for the patient and nursing staff to assess their satisfaction. The results will be processed to compare and evaluate the administration of both immunoglobulin solutions.

Eligibility Criteria:
Inclusion Criteria:

* Age =\> 18 years
* Immunodeficiency secondary to a hematologic disorder
* Patient has received at least 2 Multigam IV 5% administrations
* Patient may not have had any adverse events (grade 2 or higher according to CTCAE v4.03) during the last 2 Multigam IV 5% administrations
* Patient needs at least 2 more immunoglobulin administrations
* Signed informed consent

Exclusion Criteria:

* Patient has received less than 2 Multigam IV 5% administrations
* Patient has had an adverse event (grade 2 or higher according to CTCAE v4.03) during the last 2 Multigam IV 5% administrations
* Refusal to sign informed consent
Study Of Remission In Patients Treated For Generalized Anxiety Disorder

The aim of the study is to assess the remission rates in patients treated for generalized anxiety disorder in primary and specialized care. Factors that may influence remission such as disease history and severity of the anxiety disorder, the type of treatment, the presence of co-morbid depression or anxiety disorder as well as socio-demographic factors will also be evaluated. The study will also assess patient functioning and compare functioning in patients who do and do not achieve remission.

The aim of the study is to assess the remission rates in patients treated for generalized anxiety disorder in primary and specialized care. Factors that may influence remission such as disease history and severity of the anxiety disorder, the type of treatment, the presence of co-morbid depression or anxiety disorder as well as socio-demographic factors will also be evaluated. The study will also assess patient functioning and compare functioning in patients who do and do not achieve remission.

The objectives of the study are:

Primary: To determine the prevalence of remission in patients treated for generalized anxiety disorder in primary care and specialized care. Secondary: To determine patient functioning and work loss days and compare these in patients who do or do not achieve remission. To determine the effect of disease factors on remission rate such as disease history, duration, severity, co-morbidity with depression or other anxiety disorders. To determine the effect of treatment factors on remission rate such as setting, type of treatment, duration and adherence. To determine the effect of socio-demographic factors on remission rate such as gender, age, region (language), marital status, educational level and employment status.

This will be a cross-sectional observational study looking at the point prevalence of remission in treated patients with generalized anxiety disorder in general practice and specialized care in Belgium. General practitioners and psychiatrists will assess remission rates in patients treated for generalized anxiety disorder during 1 routine visit of these patients.

The participating physicians will have 3 months to evaluate remission at a routine visit in 5 to 10 patients that have been treated for generalized anxiety disorder since at least 3 months

Eligibility Criteria:
Inclusion criteria:

To be eligible the patient must meet all of the following:

1. Being treated for generalized anxiety disorder for approximately 3 months and not more than 12 months
2. Be at least 18 years of age;
3. Written informed consent
4. Out-patient
Determination of the Bioavailability of Short Chain Fatty Acids in Healthy Humans

The purpose of the study is to evaluate the bioavailability of acetate, propionate and butyrate in healthy humans using a stable isotope technology.

In addition the level of acetate, propionate and butyrate production from inulin will be determined using the principle of isotope dilution.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Regular dietary pattern (3 meals/day)
* Age: 18-65y
* BMI: 18,5-27 kg/m2

Exclusion Criteria:

* Intake of antibiotics 1 month prior to the study
* Abdominal surgery in the past, with the exception of appendectomy
* Intake of medication influencing the gastro-intestinal system 14 days prior to the study
* In treatment at a dietician
* Intake of pre- and/or probiotics
* Exposure to radioactivity 1 year prior to the study
* Serious chronic disease of the gastrointestinal tract
* Use of medication that affects the gastro-intestinal tract during the last 2 weeks prior to the study
* Pregnancy, pregnancy desire or lactation
* Blood donation during the last 3 months prior to the study
* Diabetes (type 1 or 2)
* Aberrant hemoglobin level (Hb) in blood. Normal between 14.0 and 18.0 g/dL for men and between 12.0 and 16.0 g/dL for women
Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan

The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group performance 0-1

Exclusion Criteria:

* Any disorder with dysregulation of glucose homeostasis
* Dumping syndrome
* History of glucose intolerance
Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy (PEP ASV)

This is a prospective, single-arm, unblinded pilot study and registry that aims to demonstrate adherence to adaptive servo-ventilation (ASV) therapy in patients with moderate to severe sleep disordered breathing who have been recently hospitalized. ASV therapy has been linked to improved outcomes in this population, but adherence to therapy is low. The AirCurve 10 ASV device that will be used for this study employs newer technologies, such as web-based monitoring and provides patients feedback, which may increase therapy adherence and therefore improve patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients 18 years or older 2. Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%) 3. Hospital admission or equivalent (such as ER visit alone or clinic visit alone) and acute decompensated HF as determined by:

  1. Dyspnea at rest or with minimal exertion AND
  2. Treatment with at least one dose of IV diuretic or ultrafiltration AND
  3. At least two of the following signs and symptoms:

  i. Orthopnea ii. Pulmonary rales that do not clear with cough iii. Congestion on chest X-ray iv. Local BNP or NT pro-BNP level:
* No current AFib: BNP≥100 pg/mL or NT pro-BNP≥300 pg/mL OR
* Current AFib: BNP≥150 pg/mL or NT pro-BNP≥450 pg/mL 4. Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr) 5. Patient is able to fully understand study information and sign informed consent

Exclusion Criteria:

1. Right-sided heart failure without left-sided failure
2. Current chronic use (within 4 weeks of registry entry) of any PAP therapy (e.g., CPAP, APAP, or bi-level) or contraindicated for PAP therapy
3. Sustained systolic blood pressure \<80 mmHg at baseline
4. Complex congenital heart disease
5. Constrictive pericarditis
6. Chronic hypoxemia as evidenced by sustained oxygen saturation ≤ 85% at rest during the day or at start of nocturnal oximetry recording or regular use of oxygen therapy (day or night)
7. Transient ischemic attack (TIA) or Stroke within 3 months prior to registry entry
8. Definite clinically evident acute myocardial infarction within 3 months of registry entry
9. Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas
10. Moderate or greater valvular heart disease as the primary reason for heart failure
11. In the opinion of the investigator, the index acute decompensated HF event was not due primarily to uncontrolled AFib with fast ventricular response rate
12. Inability to comply with planned study procedures