cyrilzakka/clinical-trials huggingface dataset:
Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

Human safety studies will be carried out to test whether red clover botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a red clover dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) will be given with four selected FDA-approved drugs to determine if the Licorice supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies predict that the licorice supplement might affect the metabolism or break down of these probe drugs.

At the start of a study, subjects will be administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples will be drawn and analyzed for the concentration of each drug over time. Afterwards, participants will take the licorice dietary supplement twice daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs will be taken again to obtain a second measure of drug concentrations in blood over time. Changes in the concentration-time curve values for each probe drug obtained before and after ingestion of the supplement would indicate that metabolism of the probe drugs is impacted by the licorice dietary supplement.

Eligibility Criteria:
Inclusion Criteria:

* healthy peri- and post-menopausal women ages 40 - 79
* non-smokers
* no-significant medical conditions as assessed by subject-reported medical history, physical examination and blood and urine chemistry screens
* no medical condition that requires chronic use of medication

Exclusion Criteria:

* known allergies or hypersensitivity to caffeine, dextromethorphan, sulfonylureas (tolbutamide), benzodiazepines, or licorice
* positive pregnancy test
* use of hormone therapy within 8 weeks of study initiation for oral agents, 4 weeks for transdermal or other topical agents
* use of caffeine products 7 days before study participation or during the study
* use of citrus products 7 days before study participation or during the study
* other prescription (with the exception of the Mirena® IUD) or non-prescription medicines within the 2 weeks prior to study initiation or during the study
* chronic diseases, such as inflammatory bowel disease, that could alter the absorption or metabolism of the probe substrates
* unwillingness to comply with study requirements
* current participation in another clinical trial
* CYP2D6 deficiency based on phenotyping at screening
* smoker
* licorice (whether as a botanical dietary supplement, candy, food, drink or otherwise) within the previous two weeks and during the study
* use of any dietary supplements within the last 2 weeks prior to study initiation and during the study
* extreme obesity (defined as \>40 BMI)
* alcohol or drug abuse
* chronic diseases such as diabetes.
Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia

The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.


Eligibility Criteria:
Inclusion Criteria:

* TASC II type D femoropopliteal lesions with intact ipsilateral femoral pulse.
* Fontaine classification stage IV (gangrene or necrosis).
* Rutherford grade III and IV category 5 and 6 with salvageable foot

Exclusion Criteria:

* heart failure
* liver failure
* renal impairment
Seroquel Therapy for Substance Use Disorders Comorbid With Schizophrenia

It is hypothesized that the atypical antipsychotic, Seroquel, will cause significant reduction in drug and alcohol cravings in patients with schizophrenia and comorbid cocaine and/methamphetamine dependence compared to the atypical antipsychotic, risperidone (Risperdal).

Patients treated with Seroquel will have less use of cocaine and/or methamphetamine as measured by the Time Line Follow-back, over a 24-week follow-up period.

Schizophrenia is a serious mental illness that afflicts approximately 1% of the population (1). Often these patients have comorbid cocaine and amphetamine dependence, which increases the severity of psychotic symptoms associated with schizophrenia, decreases treatment compliance and worsens prognosis.

The treatment of schizophrenia with comorbid cocaine and/or amphetamine dependence is complex and involves adherence to psychiatric medications, most often antipsychotic agents, along with participation in specific substance abuse treatment such as structured living, attendance at self-help group meetings, individual and group therapy and a commitment to sobriety. In the absence of specific pharmacotherapy of cocaine and amphetamine dependence, various antipsychotic medications have been compared to see if they impact comorbid cocaine and amphetamine abuse in addition to their antipsychotic effects.

The primary objective of this study is to test whether Seroquel as a mono-therapy decreases cocaine and/or methamphetamine use in patients with schizophrenia as compared to risperidone.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 19 - 65.
2. Diagnosis of schizophrenia or schizoaffective disorder with comorbid cocaine and/or amphetamine abuse/dependence as confirmed by Structured Clinical Interview for DSM-IV.
3. Comorbid diagnoses of depression, anxiety and/or personality disorders are permitted.
4. Ability to provide signed informed consent.
5. Stable general medical health.

Exclusion Criteria:

1. Dangerous to self or others.
2. Pregnancy, inability or unwillingness to use approved methods of birth control.
3. Inability or unwillingness to provide signed informed consent.
4. Diagnosis of bipolar disorder, primary major depressive disorder (As major Axis I diagnosis).
5. Inability to attend outpatient research clinic.
6. Medical conditions, which would preclude use of Seroquel.
7. Absolute need for ongoing treatment with antipsychotic other than Seroquel.
8. Medical instability defined as likelihood of needing to change prescription medication during the course of the study.
9. Patients currently taking quetiapine or risperidone.
10. Patients with unsuccessful treatment with quetiapine or risperidone.
11. Subjects with a HAM-D score of ≥20 at screening.
Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.


Eligibility Criteria:
Inclusion Criteria:

Outpatients with an acute pharyngitis erythematous or erythematopultaceous with modification of pharynx aspect and fever of ≥38° C, and patients either with or without spontaneous pharyngeal pain or upon swallowing and enlargement of the cervical lymph node (mandibular area) were eligible for inclusion. All subjects should have had a positive rapid strep test and a positive culture for Group A beta-hemolytic streptococcus.

Exclusion Criteria:

Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were excluded.
Dopaminergic Modulation of Cognition and Psychomotor Function

A recent study at our lab showed increased episodic memory consolidation and response readiness after treatment with methylphenidate in healthy volunteers. The investigators seek to replicate and extend these findings. Furthermore the pharmacological specificity of these effects will be studied. Since methylphenidate has an effect on two neurotransmitters, dopamine and noradrenaline, either could be responsible for the observed effects. In order to explore the dopaminergic contribution to this effect, the study proposed here includes not only methylphenidate but also levodopa/carbidopa, which only affects dopamine and not noradrenaline.

In this study, 20 healthy males and females between 18 and 45 years of age will participate. They will be recruited via advertisements at Maastricht University and in local newspapers.

Participants will be treated once with methylphenidate, once with levodopa/carbidopa and once with placebo. All medications will be administered orally with a capsule.

It is hypothesized that methylphenidate and levodopa/carbidopa will both enhance episodic memory consolidation and improve response readiness


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 to 45 years of age
* Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),
* Body mass index between 18.5 and 30
* Willingness to sign an informed consent.

Exclusion Criteria:

* history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness.
* history of depression, bipolar disorder, anxiety disorder, panic disorder, psychosis, or attention deficit hyperactivity disorder will be excluded from participation.
* first-degree relative with a psychiatric disorder or a history with a psychiatric disorder
* excessive drinking (\>20 glasses of alcohol containing beverages a week
* pregnancy or lactation
* use of medication other than oral contraceptives
* use of recreational drugs from 2 weeks before until the end of the experiment
* any condition in which gastrointestinal motility might carry any risk
* any sensory or motor deficits which could reasonably be expected to affect test performance
Effects of Physical Training on Adipose Tissue Metabolism and Insulin Sensitivity in the Menopausal Transition Phase

The purpose of this study is to determine if physical exercise reduces the adverse changes in adipose tissue metabolism and insulin sensitivity that occurs in women during the menopausal transition.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal OR Postmenopausal (45-57 years)
* No chronical Diseases
* BMI \> 18,5 and \< 30
* Sedentary (no regular physical activity the last 2 years)
* Either regular bleeding (premenopausal) OR no menstruation for at least 2 years (postmenopausal)
* Plasma measurements:

Premenopausal: estradiol \> 0.20nmol/l, Follicle Stimulating Hormone \< 22 IU/l and progesterone \> 2.5 nmol/l Postmenopausal: estradiol \< 0.20nmol/l, Follicle Stimulating Hormone \> 22 IU/l and progesterone from 0.3-2.5 nmol/l

Exclusion Criteria:

* Smoking
* Excessive alcohol intake
* Regular medication including hormone replacement treatment
Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries

The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery.

Drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries. Unfortunately drug eluting stents failed to demonstrate superiority over bare stents in the superficial femoral artery. We could show that a non-stent based delivery of Taxan was equal or superior to drug eluting stents in an animal model. This was both true for the coronary arteries and peripheral vessels.

In a prospective blinded trail \>135 patients are randomized either to receive Taxan locally administered with a balloon catheter during balloon angioplasty, or together with contrast media. One group serves as control. There were no limitations due to lesion length. Follow-up angiography will be after 6 months, 12 months and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Chronic Occlusions and stenosis (history at least 6 weeks) ≥70 % diameter Stenosis \> 2cm in the arteria femoralis superficialis or arteria poplitea
* Various criteria assuring ethical issues and follow up

Exclusion Criteria:

* Conditions requiring different treatment or raising serious safety concern regarding the procedure or the required medication.
* Pregnancy can not be excluded
* Doubts in the willingness or capability of the patient to allow 6 months follow up
Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine

Chronic Migraine (CM), or 15 or more migraine headaches per month, is common in tertiary headache care and is associated with a number of deleterious outcomes, especially higher disability and poorer quality of life, relative to those with Episodic Migraine (EM) defined as 14 or fewer migraine headaches per month. Limited work has begun to examine factors that increase or decrease the risk of developing CM. One factor that appears especially relevant is symptomatic medication use. The current study builds upon and expands previous work considering the influence non-steroidal anti-inflammatory drug (NSAID) and/or triptan use has on the likelihood of developing CM.

This study is a retrospective observational cohort study of data collected via mail survey and collated in the American Migraine Prevalence and Prevention (AMPP) database.

Survey results from the AMPP study will be analyzed retrospectively. The AMPP is a longitudinal, population-based, mailed-questionnaire survey. In 2004, 120,000 United States (US) households were screened and 24,000 individuals who reported severe headaches were identified and additional questionnaires have been administered annually. This analysis uses data from respondents who meet second edition of the International Headache Classification-2 (IHCD-2) criteria for EM in 2005 with follow up results in 2006, 2007, 2008, and 2009. EM is defined as 1 to 14 headaches per month and CM is defined as 15 or more headaches per month.


Eligibility Criteria:
Inclusion Criteria:

* Respondents age 18 or older at the time of survey completion
* Respondents completed the questionnaires in 2004 and at least one other year (2005, 2006, 2007, 2008, 2009)
* Based on the respondents answers to the 2004 survey, their symptoms meet the criteria for EM which is characterized by headaches meeting International Classification of Headache Disorders - 2 (ICHD-2) criteria for migraine 1-14 days a month

Exclusion Criteria:

* Responses to questions suggest that the respondent's diagnosis is not migraine or CM
Vitamin D Treatment in Ulcerative Colitis

The purpose of this study is to test blood and tissue samples of people with Ulcerative Colitis (UC) to see what effects Vitamin D3 may have on the immune system. This research is being done because it could lead to the development of new treatment for people with Inflammatory Bowel Disease (IBD).

The primary endpoint of the trial is the change in colonic permeability as a global assessment of vitamin D3 effects throughout the colon in patients with Ulcerative Colitis. Secondary endpoints will be changes in colonic tight junction protein expression, and their relationship to serum vitamin D level, VDR expression, inflammatory cytokines, and histologic inflammation

Eligibility Criteria:
Inclusion Criteria:

* Patients must be over 18 years of age
* have a diagnosis of UC as confirmed by histology.
* UC patients must have active but mild disease as confirmed by a Mayo Clinic endoscopy score from 2-4,
* not requiring medication adjustment during the trial.
* Patients must be capable of understanding the purpose, risks and expectations of study participation and willing to provide written informed consent.

Exclusion Criteria:

* Individuals on vitamin D or laxative therapy (except for purposes of endoscopy preparation),
* UC patients with fulminant colitis or active C difficile or other colonic infections,
* age\<18 year old,
* individuals with bleeding disorders will be excluded from the study.
High Protein Dairy Products and Resistance Exercise in the Elderly

Protein supplementation is one of the main recommendations for regular endurance physical exercise (RT). In older people, the need for protein increases particularly in the face of physiological and pathophysiological changes associated with the loss of muscle tissue and function, so protein intake becomes more relevant in this population. Fermented dairy products such as yogurt, and especially those with an extra protein content, have increased their popularity and consumption in the national market. Their nutritional composition is of particular interest, given their amino acid profile and in particular their high Leucine content, which could be compared with the classic protein supplements recommended for muscle gain and recovery. Objective: To analyze the effect on body composition, lipid profile, physical condition and muscle functionality induced by the intake of high protein yogurts versus Whey protein together with a muscular resistance program in elderly people. Hypothesis: The intake of high protein yogurts will lead to equal or greater gains in muscle mass, physical condition and functionality than those obtained with the intake of Whey protein together with resistance training in elderly people.Methodology: 16 healthy, lactose intolerant free, older (60-75 years old) subjects will be recruited to perform 8 weeks of muscular resistance training (RT) 3 times per week, who will be randomly supplemented with high protein yogurt (PY) or Whey protein (WP). At baseline and at the end of the intervention, body composition will be assessed by DEXA, muscle strength, maximal oxygen consumption and lipid profile. Expected Results: The YPRT group is expected to achieve similar or greater increases in muscle strength, fat-free mass, lipid profile and decrease in fat mass than the WP group.


Eligibility Criteria:
Inclusion Criteria:

* \>60 years
* Less than 1 hour of exercise a week

Exclusion Criteria:

* Lactose Intolerant
* Smoking
* Type 1 or 2 Diabetes
* Alcohol intake
* Currently taking protein, high protein yogurts, creatine, HMB or any other supplement that aims to improve muscle mass
Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study

The goal of this single arm, prospective study is to test the therapeutic response of oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks in non-diabetic MAFLD patients. The primary outcomes are the improvement of liver inflammation or fibrosis parameters after 24 weeks treatment. The adverse events were also recorded.

This is single-arm, prospective study and 50 non-diabetic MAFLD patients are enrolled consecutively at Taipei Tzu Chi Hospital. The non-diabetic definition is no previous history of diabetes mellitus and HbA1C \< 6.5%. Fatty liver was diagnosed by imaging such as liver ultrasound or histologic examination. Metabolic dysfunction was defined as overweight/obese, or more than 2 metabolic abnormalities in lean/normal weight subjects. Inclusion criteria were ALT elevation (\>35 U/L in male and \>25 U/L in female) or FIB-4 \>=1.45. Those with cancer history, systolic blood pressure \< 100 mmHg, or eGFR \< 30 ml/min/1.73m2, or history of urinary tract infection/genital yeast infection were excluded. They received oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks.

The primary outcomes are the change of liver inflammation marker (serum ALT level)or fibrosis parameters after 24 weeks treatment. The adverse events were also recorded. The severity of liver fibrosis was determined using NAFLD-fibrosis score and ultrasound-based elastography method (ARFI).

Total 6 visits Visit 1 (screening): US, ARFI, body composition measurement, BP, BMI, Waist circumference, body fat (%), AST/ALT, albumin, GGT, Cr, TG, CHO, HDL/LDL, glucose ac, HbA1C, Platelet, insulin, CRP Visit 2 (2 weeks): BP, AST/ALT, Cr Visit 3 (4 weeks): BP, BMI, Waist circumference, body fat (%), AST/ALT, albumin, GGT, Cr, TG, glucose ac, HbA1C, platelet Visit 4 (3 months):BP, BMI, Waist circumference, body fat (%), AST/ALT, albumin, GGT, Cr, TG, glucose ac, HbA1C, platelet Visit 5 (6 months): US, ARFI, body composition measurement, BP, BMI, Waist circumference, body fat (%), AST/ALT, albumin, GGT, Cr, TG, CHO, HDL/LDL, glucose ac, HbA1C, Platelet, insulin, CRP Visit 6 (Month 3 off-therapy): BP, BMI, Waist circumference, body fat (%), AST/ALT, albumin, GGT, Cr, TG, CHO, HDL/LDL, glucose ac, HbA1C, Platelet Record adverse events and number of pills left in each visits

Eligibility Criteria:
Inclusion Criteria:

* MAFLD patients (hepatic steatosis plus metabolic dysfunction
* ALT elevation (\>35 U/L in male and \>25 U/L in female) or FIB-4 \>=1.45

Exclusion Criteria:

1. diabetes history or HbA1C\> 6.5
2. cancer history
3. systolic blood pressure \< 100 mmHg
4. eGFR \< 30 ml/min/1.73m2
5. history of urinary tract infection/genital yeast infection
COVID-19 in ART: Perception and Experience

Non-urgent medical care, such as fertility treatments, has been massively postponed during the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might cause anxiety and depression among infertile couples, who are already exposed to the distressing experience of infertility and for whom the wait for a baby already appears unending. Few data are available regarding the impact of SARS-CoV-2 on pregnant women and foetus, or on fertility.

This study aims to assess the views of infertile couple regarding the potential risks of COVID during their fertility treatment and their personal experience of the COVID pandemic and their expectation for further treatment .


Eligibility Criteria:
Inclusion criteria:

- Men and women who had a fertility treatment prescribed during the past 9 months in our Fertility department

Exclusion criteria:

* Patient attending for a fertility preservation
* Patient attending for a preimplantation genetic testing (PGT-M or PGT-SR)
* Patient not fluent in French