cyrilzakka/clinical-trials huggingface dataset:
Role of Two Rehabilitative Treatments and Diet in the Modulation of Inflammation in Patients With Knee Prosthesis.

The investigators studied the influence of two aproved rehabilitative treatments, connective tissue techniques and lymphatic drainage, on acute inflammation markers. Furthermore, the role of mediterranean diet on the same values was investigated in the first postoperative period

The main objective of this study is to demonstrate the effectiveness of lymphatic drainage and connective tissue techniques in modulating systemic inflammation. Another objective is to evaluate the existence, at baseline, of a correlation between the inflammation indices and the level of adherence to the Mediterranean diet.

Methods. 34 patients were recruited, and divided into three groups. The control group followed the normal rehabilitation protocol. The other two groups were subjected, in addition to the standard treatment, to manual lymphatic drainage treatment or connective tissue techniques. The outcomes (PCR, ESR, Oedema) were recorded in three stages: upon entering the hospital, 1 week after entry and at follow-up 21 days after surgery.

Eligibility Criteria:
Inclusion criteria

* 50\<age\<80 years
* Bicompartmental knee arthroplasty
* Weight bearing 7 days after surgery
* Transfusions according to hospital protocol
* Alteration of the indices at T0
* Standard analgesic therapy

Exclusion Criteria:

* Joint replacements from other Units
* Inflammatory arthropathies
* Autoimmune / rheumatic diseases
* Obesity
* Diabetes mellitus
* Infections
Brief Behavioral Treatment for Insomnia in Cancer Survivors

The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.

A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of Brief Behavioral Treatment for Insomnia (BBTI).

Eligibility Criteria:
Inclusion Criteria:

* \> or = 4 weeks from surgery for cancer treatment; chemotherapy and/or radiation therapy; no wait for hormone therapy or targeted treatment for stage I, II, or III: breast, colorectal, prostate, lung cancer
* chronic insomnia

Exclusion Criteria:

* Other preexisting sleep disorders except those with OSA stable on CPAP
* Unstable medical illnesses
Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block

Patients with indication of shoulder surgery will be submitted to ultrasound-guided interscalene brachial plexus block with 4ml or 15ml of bupivacaine- epinephrine 0,5%- 1:200,000 at level of C5-6 roots and will be evaluated their ventilation and pulmonary aeration by electrical impedance tomography


Eligibility Criteria:
Inclusion Criteria:

* shoulder surgery
* indication of interscalene brachial plexus block
* American Society of Anesthesiology Physical Status Classification I or II

Exclusion criteria:

* refuse to participate
* previous lung or diaphragma surgeries
The Effects of Baduanjin Exercise on Meridian Energy and Heart Rate Variability in Patients Undergoing Cardiac Sugery

Cardiac rehabilitation (CR) consists of supervised exercise training in conjunction with other secondary prevention interventions. However, CR is not widely used because of distance, financial resources, work and other time constraints, gender, age, social support, illness perceptions, and psychiatric problems. Baduanjin is a type of movement-based mind-body intervention. It is a form of traditional practice designed to promote physical and psychological health, manage symptoms, and relieve stress during illness. Patients with heart disease have frequently used it. The impacts of a Baduanjin exercise-based cardiac rehabilitation program for patients recovering from CAD under coronary artery bypass graft (CABG) or valve replacement on Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) and heart rate variability (HRV) has yet to be assessed. This trial evaluates whether the Baduanjin exercise would provide effective meridian energy and HRV in patients following CABG.


Eligibility Criteria:
Inclusion Criteria:

* 25-70 age range
* Undergoing open heart surgery
* Hemodynamically stable
* Ambulatory
* No advanced vision defect
* The physician authorized by the operating physician for participation in the exercise
* Patients who agreed to participate in the study.

Exclusion Criteria:

* The presence of pulmonary, neurological, musculoskeletal disease limiting participation in exercise training
* Patients at high risk (ejection fraction below 40 percent)
* Dissectant aneurysm
* Patients who cannot be cooperative in verbal and / or auditory terms
* Psychological and / or perceptual cooperative patients
Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)

This study will evaluate the feasibility of an 8-week vegan whole-food, plant-based dietary intervention in subjects with low risk CLL who are undergoing observation. Over the course of 8 weeks, participants will attend weekly group cooking classes via Zoom lead by a RD. Participants will also attend weekly individual meetings with a health coaches to assist with adherence to the dietary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have a diagnosis of low-risk CLL according to the modified Rai staging criteria for a minimum of 12 months and are currently undergoing observation.
* Access to a computer or tablet and Zoom.

Exclusion Criteria:

* Have active disease and are currently receiving pharmacologic treatment for CLL
* Have previously received treatment for CLL
* Are currently following a vegan or vegetarian diet
* A previous or current diagnosis of disordered eating including anorexia, bulimia, binge eating disorder or avoidant/restrictive food intake disorder.
* A diagnosis of Type 1 diabetes
* A diagnosis of Insulin dependent type 2 diabetes
* Currently pregnant or planning to become pregnant
Therapeutic Antioxidant Supplementation

A remotely administered study, non-randomized, non-blinded, controlled parallel assignment phase 2 trial to determine if oral inosine or inositol hexaphosphate will provide an effective long-term therapy to combat or slow neural damage progression either concurrently with existing iron chelation therapy or during the natural course of the disorder. Clinical changes in hearing, balance, and mobility, and cognition will be assessed for 36 months through patient-reported outcomes of study assigned assessments.

Capsules containing over-the-counter dietary supplement formulas of inosine 500 mg or 500 mg of inositol hexaphosphate(IP6) will be taken orally, two capsules two times per day for 36 months. Initial screening will determine patient arm assignment.

Before dosing begins, patients will submit copies of previous audiogram results (3yrs), radiology reports (3yrs), and MRI series (3yrs) if available and complete baseline assessment activities: Montreal Cognitive Assessment (MoCA) administered remotely, Timed Up, and Go (TUG), 2-Minute Walk Test (2-MWT), The Activities-specific Balance Confidence (ABC) Scale, iSS-QoL (custom) patient outcome reported

Assessment will take place four times: baseline, end-of-year 1 (12mo), end-of-year 2 (24mo), end-of-study (36mo).

Eligibility Criteria:
Inclusion Criteria:

Confirmed diagnosis of iSS (superficial siderosis of the CNS)

No illegal drug use

No history of myocardial infarction or stroke

No history of severe chronic obstructive pulmonary disease

Can safely swallow large capsules

Exhibits at least one confirmed iSS related symptom: Hearing Loss, Balance, Memory/Cognitive problems

Does not have a known hypersensitivity or intolerance to any study antioxidant

Has not taken part in another treatment study for any condition within the last 30 days (about four and a half weeks)

Not currently pregnant or breastfeeding

Exclusion Criteria:

Inosine Arm Exclusion :

Diagnosed with urate urolithiasis, or recurrent urolithiasis, all unknown type

History of Gout

History of Kidney Stones

P6 Arm Exclusion

Long-term anticoagulant

Known or suspected active bleed into the CNS

Currently undergoing deferiprone chelation therapy

Plan to begin deferiprone chelation therapy within three years

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Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations

This study is primarily designed to assess the safety and the tolerability of Debio1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment does not exist or is not indicated.

The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally administered daily to these patients, in order to determine the recommended dose.

The main objective of Part B is to evaluate the safety profile at the recommended dose, in a larger cohort of these patients.


Eligibility Criteria:
Inclusion Criteria

* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results
Chewing Efficiency Measured by a Two Colour Chewing Gum Test in Amyotrophic Lateral Sclerosis (ALS) Patients?

Study aims: The primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.

Study center: University Hospitals of Geneva Study type: Cohort study with matched controls Study population: 25 ALS patients included in the multidisciplinary cohort study of the University Hospital Geneva between October 2012 and October 2014 and followed for 3 years maximum and 25 controls, matched for age, sex and dental status.

Study duration: Inclusion from October 2012 to October 2016. Follow-up for 3 years.

Study hypothesis: Chewing efficiency, maximum bite and lip force decrease with time in ALS patients and may be a marker of texture adaptation and PEG necessity.

Study aims: The primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.

The secondary aims are to determine, in ALS patients, whether:

* Maximum bite and lip force decrease.
* Chewing efficiency, maximum bite and lip force decrease more in ALS patients with bulbar than with spinal onset.
* Chewing efficiency and bite force correlate with energy intakes, nasofibroscopic assessment, and a validated swallowing questionnaire.
* Saliva volume increases with time and progression of disease and influences masticatory efficiency.
* Saliva volume is associated with nasofibroscopy assessment.

Methods : Every three months, we will perform:

* As part of the ongoing cohort study (already accepted by the Ethical Committee) calculation of energy intakes through a 24h recall, nasofibroscopy, swallowing questionnaire and score of disease severity.
* As part of this study: assessment of dental status at first visit, chewing efficiency test by a with a colour mixing ability test, maximum voluntary bite and lip force, saliva volume and calculation of a 3-day dietary recall instead of a 24h recall.

Statistics: Evolutions with time and between groups, of chewing efficiency, bite and lip force will be assessed by repeated measures ANOVA. Correlations between two continuous variables will be examined by Spearman's correlation coefficients at the different time points. Correlations between a continuous variable and a binary variable (nasofibroscopic assessment) will be explored by logistic regression with mixed effect model.

Eligibility Criteria:
Inclusion Criteria:

* ALS patients
* \> 18 years
* Participation in the cohort study

Exclusion Criteria:

* Refusal of participating in the cohort study
* Presence of PEG
To Assess Immunogenicity of Coronavirus Disease 2019 (COVID-19) Vaccine in Cancer Patients Receiving Cancer Treatment

This is a trial of prospective collection of serial blood samples after administration of COVID-19 vaccine in patients with cancer who are receiving active cancer treatment, planned to start therapy with 14 days of consent, or have had stem cell transplant. Cancer treatments and administration of vaccine are not controlled by the study.


Eligibility Criteria:
Inclusion Criteria:

* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
* Males and females age ≥ 18 years
* Patients with breast cancer, lung cancer, malignant melanoma or who have undergone stem cell transplant or chimeric antigen receptor (CAR) T cell therapy for a hematologic malignancy.

Other cancer types including hematologic malignancies may be allowed if they are receiving treatments outlined in section 4.1.4

* Solid Tumor patients and those with hematologic malignancies: Currently receiving active anti-cancer therapy, or planned to start within 14 days, with intravenous cytotoxic chemotherapy (oral or intravenous), intravenous chemoimmunotherapy combination, immunotherapy alone, an oral CDK 4/6 inhibitor. (This does not apply to recipients of stem cell transplant and CAR T therapy)
* Therapy may be neo/adjuvant or for metastatic disease
* Eastern Cooperation Oncology Group (ECOG) Performance status (PS) of 0-2

Exclusion Criteria:

\* Life expectancy of \< 12 months
The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables

The investigators wish to study the effect of retaining potassium. The participants have essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The participants will ingest tablets for 28 days before being examined. We will perform a 24 hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we also examine the patient using a SphygmoCor.

Purpose of the study is to examine the effect of amiloride and spironolactone on

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

Eligibility Criteria:
Inclusion Criteria:

* hypertension,
* BMI 18,5-30,
* non-smoker

Exclusion Criteria:

* Smoking
* Not using contraceptives
* Other illnesses
* Drug or alcohol abuse
Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo

This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study.


Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent.
2. Male or female ≥ 18 years of age at time of screening
3. Stable (without new patches ≥ 1 year) or unstable (with new patches for the last 1 year) vitiligo
4. VASI of ≥ 4 at screening and baseline

Exclusion Criteria:

1. Segmental vitiligo, focal, or mixed Vitiligo
2. Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment
3. History of alcohol or drug abuse in the previous 2 years
4. Subjects who were submitted to melanocyte transfer

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SpO2 System Accuracy Testing With Different Sensors

A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.

The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent or have a legally authorized representative provide written informed consent
* Subjects who are 18-55 years of age
* Subjects must be willing and able to comply with study procedures
* HbCO\<3% (for smokers only)

Exclusion Criteria:

* Subject or a legally authorized representative is unable to provide written inform consent.
* Subjects that are considered morbidly obese (defined as BMI \> 39.5),
* Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test,
* Smokers with COHb levels \>3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of \>3% with a Masimo Radical 7 (Rainbow).
* Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
* Subjects with known heart or cardiovascular conditions,
* Female subjects that are actively trying to get pregnant or are pregnant,
* Subjects taking blood thinners or medications with aspirin or other antiplatelet medication in them (applies only to arterial draw study),
* Subjects with Systolic blood pressure \>140mmHg,
* Subjects with Diastolic blood pressure \>100mmHg,
* Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
Prevention of Esophageal Varices by Beta-Adrenergic Blockers

The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).


Eligibility Criteria:
Inclusion Criteria:

* Liver biopsy compatible with cirrhosis.
* Absence of gastroesophageal varices.
* An increased hepatic venous pressure gradient (HVPG) (6mmHg).
* Age over 18 and below 76 years.
* Informed, written consent.
* Absence of exclusion criteria.

Exclusion Criteria:

* Presence of ascites that requires specific treatment (diuretics, paracentesis, peritoneo-venous shunt, etc).
* Proven hepatocellular carcinoma by radiological or histological criteria.
* Splenic or portal vein thrombosis by Doppler-ultrasound.
* Presence of any concurrent disease that is expected to decrease life expectancy to less than one year.
* Patients taking diuretics, beta-blockers, clonidine, prazosin, nitrates, molsidomine and any drug which may have an effect on splanchnic hemodynamics/portal pressure.
* Patients participating in other pharmacological randomized clinical trials.
* Patients with primary biliary cirrhosis and primary sclerosing cholangitis will also be excluded since these entities have a slower progression of the disease, are usually enrolled in other clinical trials and are transplanted at an earlier stage.
* Contraindications to beta-blockers: asthma, COPD with positive broncoconstrictive test, heart failure, A-V block, aortic valve stenosis, organic psychosis, insulin-dependent diabetes, hypersensitivity to beta-blockers.
* Women who are pregnant, nursing or of childbearing potential and who are not using oral or mechanical contraception.
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells

Mesenchymal stem cells have capability to differentiate into hepatocyte and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells through intrahepatic arterial catheterization.

The population of the liver cirrhosis patients is enormous in Japan and the only radical treatment for them is liver transplantation: however, the number of giving donor is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the cirrhotic patients will undergo intrahepatic arterial administration of autologous adipose tissue derived stromal cells through catheter.

Eligibility Criteria:
Criteria defined in the implementation protocol
Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis

Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.


Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:

  1. Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
  2. A genotype with two identifiable mutations consistent with CF (∆F508 homozygous or two alleles known to cause a class I, II, or III mutation)
* Have an FEV1 ≥30% of predicted normal as defined by age, gender, and height

Exclusion Criteria:

* Oxygen saturation \<90%
* Changed in treatment regimen within 2 weeks prior to screening
* Antibiotics regimen change \< 4 weeks before screening
* Persistent colonization with Burkholderia cepacia
* Serum IgA \< 50% of lower level of normal