cyrilzakka/clinical-trials huggingface dataset:
Effect of Resveratrol and Vitamin C on Insulin Resistance Among Postmenopausal Women

Hormonal and metabolic changes because of postmenopause increase body weight, central abdominal fat, alter lipid profile and insulin resistance, those factors increase the risk up to 60% to develop metabolic syndrome, diabetes and cardiovascular diseases. Because there is no efficient antioxidant therapy in postmenopausal women, this study proposes a therapy with resveratrol and vitamin C to increase the total antioxidant capacity; as well as to decrease insulin resistance and in consequence decreased the risk of diabetes, metabolic syndrome and cardiovascular disease

Currently, there are not studies that demonstrate an efficient antioxidant therapy in postmenopausal women, to increase the total antioxidant capacity and to decrease insulin resistance and biochemical parameters of cardio-metabolic risk. Therefore, the aim of this study is to evaluate the effect of the co-administration of resveratrol and vitamin C on insulin resistance and antioxidant capacity by a double-blind randomized clinical trial. A population of 270 postmenopausal women will be studied, stratified into 3 groups:

Group 1: Three-month administration of vitamin C 500 mg daily + placebo Group 2: Three-month administration of resveratrol 500 mg daily + placebo Group 3: Three months administration of vitamin C 500 mg daily and resveratrol 500 mg daily as antioxidant therapy.

All participants will be monitored monthly for a period of 3 months: glucose, insulin, uric acid, Homeostatic Model Assessment (HOMA), total cholesterol (TC), triglycerides (TGC), High density lipoproteins-cholesterol (HDL- C), low density lipoproteins-cholesterol (LDL), blood pressure, body mass index (BMI). The antioxidant efficiency in erythrocytes by the quantification of antioxidant enzymes (superoxide dismutase, catalase, glutathione reductase and glutathione peroxidase), as well as total antioxidant capacity in plasma. In order to corroborate the oxidative damage, the product of the lipoperoxidation malondialdehyde and the carbonylation of proteins will be evaluated by spectrophotometric techniques before and three months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with early postmenopause according to STRAW classification.
* Insulin resistance determinated by HOMA ≥ 2.5.
* Not use of metformin, bezafibrates and / or statins, three months before enter to the study
* No indication of hormone replacement therapy.
* Sign the informed consent.

Exclusion Criteria:

* Women who present pathologies such as: Diabetes Mellitus, rheumatoid arthritis, lupus, neoplasms of any type, HIV, or kidney disease during the course of the study.
* Women who during the development of the protocol require hormone replacement therapy.
* Any type of surgical intervention during the following of the study.
* That the patient wishes to withdraw from the study.
* That the patient does not complete with 80% of adherence to the treatment
Effects of Cannabidiol on Burnout Syndrome and Empathy of Caregivers of Older Adults

Burnout syndrome is an occupational disease that has affected health care providers, for example, caregivers of older adults. This syndrome negatively affects physical and psychological health, which may reflect on the mental health of the caregiver and the care provided to the older adults. Interventions have been developed to minimize the impacts of burnout. Thus, this study has two main objectives: 1) to identify the effect of cannabidiol on indicators of burnout and empathy of caregivers of older people with functional dependence for activities of daily living; 2) identify possible associations between burnout indicators, empathy levels and their domains, and quality of care. This is a two-phase study (i.e., Phase 1: cross-sectional; Phase 2: clinical trial). In Phase 1, caregivers will answer questionnaires developed by researchers for sociodemographic characterization, care and satisfaction of care. In addition, they will complete instruments to assess the functional dependence of the older people - EIAVD, depressive symptoms - PHQ-9, social support - EAS, Burnout syndrome - MBI and Empathy - EMRI and MET. In Phase 2, caregivers will be randomized to cannabidiol or placebo intervention. Caregivers with number 0 will be allocated to the intervention using cannabidiol (300mg - divided into two times a day) and those drawn with number 1 will be allocated to the placebo group. Both interventions will be performed for four weeks. Caregivers will fill in the MBI, EMRI, MET, NPI and QAO instruments before and after the intervention. UKU-SERS will also be applied to evaluate side effects, IECC to assess the impact of intervention on care and CGI to assess severity and response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Total score 4 in the IEAVD
* Score on the emotional exhaustion subscale of MBI 9 and/or depersonalization 6 and/or; professional achievement 10
* Low level of empathy in the EMRI scale (i.e., total score 71)
* In addition, they should have a score of 10 on the PHQ-9, indicating absence of expressive depressive symptoms

Exclusion Criteria:

* Not have the availability to participate in this phase of the research will be excluded
* Who have ceased to exercise the position of carer of a person aged 60 years or more
* Who no longer perform minimum workload of six hours daily and
* Not complete the protocol of the intervention received.
Topical Ionic Contra-Viral Therapy in Actinic Keratosis

To explore the pharmacodynamics and evaluate safety, tolerability and clinical efficacy of ICVT comprised of digoxin and furosemide (dual agent), digoxin (single agent), furosemide (single agent) in patients with AK.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female subjects 18 years or older with verified condition of general good health (with exception of AK)
* Confirmed clinical AK diagnosis by dermatologist
* Subjects must have at least 2 facial fields of at least 25 cm² (but preferably \>35 cm²) present at screening and baseline visit where more than 2 AK lesions are visible in each field (preferably the forehead, temple or cheek)
* Subjects must be able to participate and willing to give written informed consent and to comply with the study restrictions
* Subjects must be able to communicate well with the investigator in Dutch
* Subjects willing to refrain from using other topical products in the treatment area, or prohibited medication for the duration of the study
* Subjects must be willing to limit sun exposure of the involved skin to the extent vocationally possible
* Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.

Exclusion Criteria:

* Have used or received any treatment for AK in the treatment area within 28 days prior to enrollment (including topical medications, immunosuppressive or immunomodulating agents, phototherapy, oral retinoids, or other therapies for AKs)
* Have any current pathologically relevant skin conditions in the field area other than AK (e.g. squamous cell carcinoma or basal cell carcinoma).
* Have a known hypersensitivity to any of the investigational product ingredients, including digoxin and furosemide.
* Current use of systemic digoxin or furosemide.
* Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year
* Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening or intention to donate blood or blood products during the study.
* If a woman of childbearing potential, pregnant, or breast-feeding, or planning to become pregnant during the study.
CBT for Premature Ventricular Contractions

The purpose of the present interdisciplinary research program is to develop and evaluate a disease-specific cognitive behavior therapy (CBT) protocol to increase quality of life (QoL) and reduce symptom burden in patients with Premature Ventricular Contractions (PVC).

Patients will be recruited in collaboration with arrythmia specialist units in Stockholm and through advertisement in local newspapers and social media. All patients giving informed consent will be screened thoroughly by the research nurse and a psychologist before included by the study cardiologist. 20-30 patients that meet eligibility criteria will be included and receive 8-10 sessions of cognitive behavior therapy during 8-10 weeks. Due to the current Covid-19 pandemic, treatment will be delivered face-to face through a secure digital platform. The psychologist delivering the treatment will have direct access to the study cardiologist during treatment. Follow-up at 3 and 6 months.

Eligibility Criteria:
Inclusion

* 18-70 years old
* PVCs that cause moderate to severe symptoms and leads to significant distress or interferes with daily life.
* Optimal medical treatment in the opinion of the treating physician.
* Able to read and write in Swedish.

Exclusion

* Structural heart disease including previous myocardial infarction, heart failure with preserved or reduced left ventricular ejection fraction, valvular disease, previous cardiac surgery.
* Other arrhythmia or severe medical illness;
* Scheduled for ablation therapy or any other cardiovascular intervention
* Any medical restriction to physical exercise.
* Severe depression or risk of suicide;
* Alcohol dependency.

All patients will undergo thorough cardiological and psychological assessment to ensure that eligibility criteria are met.
Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants

Femaltiker is a food for special medical purposes with a unique composition. Because beer, but not ethanol, has been reported in a number of studies to stimulate prolactin levels and breastmilk production, polysaccharide from barley was chosen as a potential galactogogue. To verify our assumption, a randomized, double blinded research with placebo was performed. The study was conducted according to good clinical practice and 10% of output data was audited by the outside monitor. The research was conducted from 14 April 2014 to 7 October 2015 in two NICUs with consent of the ethics committee on Medical Warsaw University.

The traget population consisted of volunteers women who delivered infants at \< 37 weeks gestation. Criteria of exclusion were: hypothyroidism and diabetes type I or II diagnosed and treated before pregnancy.

The schedule of the study included three visits with in certain point time during two weeks postpartum. During the study patients had taken twice a day product or placebo, respectively. The protocol of the study included :

* Three consecutive blood collections for examination of prolactin level on every visit (10 min beforeBlood examination of prolactin level in triplet on every visit (10 min before breastfeeding session, 10 min after beginning of breastfeeding and 10 min. after finishing of breastfeeding.)
* Filling pumping log to control variation in the milk yield and efficacy of lactation.
* Measurement of the volume of milk producing before blood examination (directly in case of pumping by the mother or indirectly based on weight of the baby before and after feeding)
* Interview with lactation consultant concerning patient's self-estimation of lactation efficacy Data collection was done using the CRF in the paper form which were then put tto the database in ExcelDocuments.

Eligibility Criteria:
Inclusion Criteria:

* mothers of preterm infants (born before 37 completed weeks of pregnancy)

Exclusion Criteria:

* hypothyroidism
* diabetes type I or II diagnosed and treated before pregnancy
* participating in other study
The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors

The purpose of this study is to use ambulatory blood pressure monitors to investigate whether enalapril is superior to lisinopril in managing nocturnal hypertension in patients with resistant hypertension currently treated with daytime angiotensin converting enzyme inhibitors.

Resistant hypertension is defined as blood pressure \> 140/90 mm Hg while adherent to three or more antihypertensive medications or \< 140/90 mm Hg treated with four or more antihypertensives. Patients with resistant hypertension may be at risk for elevated nighttime blood pressure \>120/70 mm Hg and "non-dipping" (night/day blood pressure \> 0.9). A higher rate of cardiovascular events occur during the "morning surge" partially attributed elevated nighttime blood pressure due to increased renin angiotensin aldosterone system (RAAS) activity. Angiotensin converting enzyme inhibitors (ACEIs) suppress RAAS activity

This prospective randomized parallel-group pilot study will occur at Memorial Family Medicine. Eligible patients will undergo three study visits over a 5-8 week span. After providing written informed consent, patients will complete an initial screening visit assessing 25 hour blood pressure using ambulatory blood pressure monitors. Patients will continue the study if they are found to have a nighttime blood pressure \>120/70 mm Hg. Patients continuing the study will be randomly assigned to equivalent dose lisinopril or enalapril treatment arms and their administration time will be changed to "bedtime." At the final visit, patients will complete a final ambulatory blood pressure analysis to reassess nighttime blood pressure and dipping status.

It's expected that patients with enalapril treatment will have superior nighttime blood pressure reduction compared to the lisinopril treatment group. If the expected outcome occurs, more patients in the enalapril group will meet their nighttime blood pressure goal (\<120/70 mm Hg) and exhibit a "dipping pattern." Current evidence suggests that patients with normal nighttime blood pressure and dipping pattern are at a lower risk for cardiovascular morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinic blood pressure \> 140/90 mm Hg on 3 antihypertensives or clinic blood pressure \< 140/90 mm Hg on 4 antihypertensives
* Currently treated with an angiotensin converting enzyme inhibitor

Exclusion Criteria:

* Chronic kidney disease (CKD) stage 4 or worse
* Pheochromocytoma
* Unstable cardiovascular disease Stroke, Transient Ischemic Attack, Unstable Angina, or Myocardial infarction in the last 30 days
* Hyperaldosteronism
* Current pregnancy
* Shift worker at night
* Presenting blood pressure \> 180/110 mm Hg
The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial

Randomized controlled trial examining platelet rich plasma versus corticosteroid injection in partial thickness rotator cuff tears or tendinopathy.

We performed a randomized controlled trial on patients with imaging-shown rotator cuff tendinopathy or partial thickness tearing. Patients were randomized to receive either platelet rich plasma or corticosteroid. Follow-up was done at 6 weeks, 3 months and 12 months following injection.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* MRI or US evidence of supraspinatus tendinopathy or partial thickness tearing
* symptomatic for minimum of 3 months
* patient has exhausted a course of adequate conservative treatment (including but not limited to home/out patient physical therapy, oral analgesics, and/or shoulder injections)

Exclusion Criteria:

* prior surgical intervention on affected shoulder
* full thickness rotator cuff tear
* concomitant ipsilateral shoulder pathology (i.e. osteoarthritis, inflammatory arthritis)
* confounding cervical neck pain or radiculopathy
* more than 3 previous CS injections
* a CS injection within 6 months of study intervention
* elite level athlete
* worker's compensation case
* litigation or secondary gain issues
* unwilling or unable to provide informed consent or complete study outcomes
Long-Term Follow-up of Adult With Atorpphic Scars Treated With TRTP-101

CIC101-01-LT is a long-term follow-up study of subjects treated with TRTP-101 and will evaluate the long-term safety and efficacy of TRTP-101.

The long-term safety of TRTP-101 was evaluated by participants in the CIC101-01 clinical trial and followed up for 5 years for serious adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Received TRTP-101 in clinical trial CIC101-01
* Provided written informed consent to participate in this study

Exclusion Criteria:

* Judged to be unsuitable to participate in this long-term follow-up
Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis

The main objective of this trial is To evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis.

A randomized controlled trial will be performed with 76 patients with knee osteoarthritis. The participants will be randomly assigned into either a control group (no exercises; they will keep their recommended clinical treatment) or an intervention group which will receive 8-week physical therapy exercises, three times per week, under the supervision of a physiotherapist. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.

The subjects will be evaluated in 3 different moments (Baseline, immediately after treatment and 8 weeks follow-up).

The hypothesis of this study is that the intervention group will decrease pain and medication intake, and improve functional performance, increase isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis (KOA) based on clinical and radiological criteria of American College of Reumathology;
* KOA (Grade II and III - Radiological classification of Kellgreen and Laurence) in medial compartment of knee;
* Knee pain between 30 and 80 on the visual analogue scale;
* BMI \< 35 kg/m2.

Exclusion Criteria:

* KOA isolated (Grade II and III - Radiological classification of Kellgreen and Laurence) in lateral compartment of knee;
* Lower limb strength training (3 times per week);
* Wear minimalist shoes for at least 6 hours a day and 5 days a week;
* Physical therapy in the previous 3 months;
* Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively;
* Previous history of surgery on knees, ankles and hips in the last 2 years;
* Neurological disease;
* Inflammatory arthritis (eg. rheumatoid arthritis);
* Asymptomatic OA of one or both knees.
Clinical Applicability of pCASL as a Substitute for FDG-PET in MCI and SCD Patients

The goal of this observational study is to compare cerebral perfusion patterns with pseudo-continuous arterial spin labeling (pCASL) and brain metabolism patterns with fluorodeoxyglucose-position emission tomography (FDG-PET) in patients with mild cognitive impairment (MCI) and subjective cognitive decline (SCD). The main questions it aims to answer are:

* Do pCASL sequences identify hypoperfusion patterns that correlate well with FDG-PET hypometabolic patterns?
* Are there differences in this correlation in terms of cerebrospinal fluid (CSF) profiles?
* Can hypoperfusion patterns in pCASL predict conversion to dementia? Participants will undergo brain 3 Tesla magnetic resonance imaging (MRI), FDG-PET, lumbal puncture and blood collection to analyze amyloid beta and tau, yearly detailed neuropsychological tests for three years.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild cognitive impairment or subjective cognitive decline according to established criteria
* Clinical Dementia Rating scale of 0 or 0.5
* Signed informed consent before study entry

Exclusion Criteria:

* Contraindication to brain MRI, FDG-PET or lumbar puncture
* Secondary causes of cognitive decline
* Known major neurological or psychiatric comorbidities
* History of substance or alcohol abuse
* Known causes of cerebral brain perfusion alterations
* Enrollment in anti-amyloid or anti-tau drugs trials
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.

The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma

  * Age 18-70 years
  * ECOG performance status 0-2
  * Ann Arbor stage II-IV
  * 8.Subjects who in line with the testing standard of the clinical trial laboratory
  * Life expectancy ≥ 3months

Exclusion Criteria:

* • systemic lymphoma involved CNS.

  * Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases.
  * uncontrolled infections (including HBV, HCV, HIV/AIDS)
  * Subjects who prepared for transplantation
  * Pregnancy or active lactation
Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

A prospective, open post-market clinical investigation that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heal cracks, calluses and/or dry feet. The investigation population will consist of 48 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will all be treated with the study product, Nåva Foot Cream. The duration of the investigation is estimated to 6 months, including a 2-month recruitment period and 2-month follow up period.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form
2. \> 18 years of age
3. Tinea pedis (Athlete's foot) confirmed with positive mycological culture for a dermatophyte
4. Total score of 6-16 when grading the eight sign and symptoms of tinea pedis (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis, odour) using a 4-point severity scale (0=absent, 1= mild, 2= moderate, 3=severe)

   o Score of 2 or higher required in at least one of the following: erythema, pruritus, macerations or odour
5. Score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses and dry feet (hyperkeratosis) using a 5-point severity scale (0=absent, 1= mild, 2= moderate, 3= advanced, 4=severe) age

Exclusion Criteria:

1. Patients with negative mycological culture
2. Severe tinea pedis interdigitalis (Athlete's foot) total score of grading sign and symptoms \> 16
3. Women pregnant or lactation at time of enrolment
4. Patients using medicinal topical antifungal therapy within 4 weeks prior to study start
5. Treatment with oral terbinafine, itraconazole or fluconazole within 6 months prior to start of study
6. Treatment with other systemic antifungals within 12 weeks prior to start of study
7. Treatment with systemic corticosteroids or immunosuppressants within 6 weeks prior to start of study
8. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate
9. Any patient that according to the Declaration of Helsinki is unsuitable for enrollment