cyrilzakka/clinical-trials huggingface dataset:
Effects of Metformin and Fish Oil on Treatment With Clozapine

One purpose of this study is to test whether adding metformin will limit some of the unwanted effects of clozapine, compared to not adding metformin. Metformin is a medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of type-2 diabetes. Studies have found that people with type-2 diabetes often lose some weight when they take metformin, however the FDA has not approved metformin for weight loss, so for this study the use of metformin is investigational. This study will test whether metformin can help people with schizophrenia or schizoaffective disorders lose weight.

Another purpose of this study is to test whether adding fish oil will improve the benefit of clozapine and/or limit some of the unwanted effects of clozapine, compared to not adding fish oil. Fish oil is a medication used to reduce levels of some fats (triglycerides) in blood. Some studies have found that adding fish oil reduces psychosis (voices, suspiciousness). However the FDA has not approved fish oil for reducing psychosis, so for this study the use of fish oil is investigational. This study will test whether fish oil can help people with schizophrenia or schizoaffective disorders have less psychosis. Fish oil is not an antipsychotic medication.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients with clinical diagnoses of schizophrenia or schizo-affective disorder
* between 18 and 60 years of age
* patients whose treating clinicians have recommended treatment with clozapine (and the patients have agreed and provided signed informed consent for treatment with clozapine)

Exclusion Criteria:

* patients who have contraindications to metformin use, such as:

  * a diagnosis of congestive heart failure
  * renal impairment (serum creatinine \> 1.5 in males; \> 1.4 in females)
  * hepatic disease (AST or ALT \> 2.0 times upper limit of normal (ULN)
  * positive hepatitis B surface antigen or hepatitis C antibody
  * total bilirubin\>1.2x ULN; majority conjugated
  * metabolic acidosis (serum CO2 \< lower limit of normal),
  * known hypersensitivity to metformin,
  * recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material
  * alcohol abuse/dependence within the past month
  * concurrent treatment with drugs that are known to increase metformin blood levels including furosemide, nifedipine, and cationic drugs including cimetidine, amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, triamterene, trimethoprim, and vancomycin
* patients with blood dyscrasias that could be worsened by added fish oil
* women who are pregnant or breastfeeding
Development,Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire

The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis.

Cystic fibrosis (CF) is an inherited disease characterized by pulmonary involvement. Children with CF may have obstructive lung disease and related dyspnea, which may progress to respiratory failure and mortality. Dyspnea may lead to activity limitation. Parents who take care of children with CF may be protective of their children's social environment for some reasons such as the risk of infection. The Breathlessness Beliefs Questionnaire (BBQ) is a Turkish validated scale developed to assess dysfunctional beliefs about dyspnea. Based on the idea that parents may develop dysfunctional dyspnea belief behavior in their children with CF, the aim of this study was to develop a caregiver version of the BBQ (The Breathlessness Beliefs Questionnaire Caregiver Version-BBQ-C) and to investigate the validity and reliability of the scale in assessing dysfunctional dyspnea beliefs in parents of children with CF.

Eligibility Criteria:
Inclusion Criteria:

* To be between 25-75 years old,
* To be literate in Turkish,
* Being a mother, father or other caregiver of a child,
* Voluntarily agreeing to participate in the study,
* Be taking care of the child for at least one year

Exclusion Criteria:

* Having cognitive impairment at a level that prevents cooperation with the scales,
* Not living in the same household with a child with cystic fibrosis.
Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection

To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment.


Eligibility Criteria:
Inclusion criteria:

Patients aho have a positive serology HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA or HIV culture and are highly pre-treated and virus resistant to multiple protease inhibitors.
Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine

The purpose of this study is to determine the effectiveness of melatonin 3 mg compared to placebo and amitriptyline 25 mg in the preventive treatment of migraine.

The investigators propose a study of patients with migraine (episodic) with or without aura, according to the criteria of the International Headache Society (IHS) 2004. This will be a randomized clinical trial, prospective, double-blind, placebo-controlled, comparing the efficacy of melatonin 3 mg and amitriptyline 25 mg for migraine prevention. The length of the inclusion of the study will be 24 months. This study's general objective is: to evaluate the effectiveness of melatonin in the preventive treatment of migraine and compare it to placebo and amitriptyline.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman 18 to 65 years of age.
* Meets diagnostic criteria criteria of International Headache Society (IHS) 2004 (2) for migraine with and / or without aura.
* Frequency from 2 to 8 migraine attacks per month
* Top of crisis over a year and age of onset less than 50 years of age.
* Patients want to participate in the study, and able to give informed consent.
* If women, the patient must be willing to use an acceptable method of birth control (eg, a hormonal contraceptive, intrauterine device, diaphragm with spermicide or condom with spermicide, or refer abstinence).
* Patient able and willing to remain on their medications throughout the study.
* Accept the guidelines of the study by filling out the diary and clinical scales.

Exclusion Criteria:

* Any medical condition that places the patient at risk with its exposure to melatonin or amitryptiline
* Use of alcohol and drugs.
* Be receiving prophylactic medication in the last three months.
* History of hemiplegic migraine, basilar, Ophthalmoplegic or stroke.
* Headache secondary to head trauma or a whiplash neck injury (whiplash).
* Pregnant or breastfeeding. Women planning to become pregnant or of childbearing age without acceptable method of contraception.
* Women who began taking oral contraceptives or who switched their oral contraceptive regimen in the 6 months prior to the start of the study.
* Allergy or known hypersensitivity to study medication or its components.
* Participation in another clinical study one month before inclusion.
Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

The purpose of this study is to evaluate in a prospective study the efficacy of intravitreal autologous plasmin enzyme in macular edema and to analyze the fibrinolytic system in vitreous body.

Autologous plasmin enzyme has been used to liquefy the gel structure of the vitreous body and to decrease the adherence of the posterior vitreous cortex to the inner limiting membrane in clinical studies. The investigators performed intravitreal autologous plasmin enzyme for macular edema. in addition, the investigators collected vitreous body in macular edema and analyzed fibrinolytic system.

Eligibility Criteria:
Inclusion Criteria:

* eyes with macular edema
* those who showed poor outcomes in visual acuity or macular thickness after grid laser,triamcinolone,or bevacizumab therapy or a combination of these treatments.

Exclusion Criteria:

* uncontrolled blood pressure (systolic and diastolic blood pressure greater than 150 and 90 mm Hg, respectively)
* renal insufficiency
* intraocular surgery or any intravitreal treatment during the previous 3 months
* history of ocular hypertension and/or glaucoma
A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism

ST-1891-201 is a multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy with ST-1891 compared to levothyroxine in patients with primary hypothyroidism.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary hypothyroidism
* On continuous thyroid replacement therapy with levothyroxine for at least 12 months immediately prior to Screening
* On a stable daily dose of levothyroxine for the 3 months prior to Screening
* Willing to give written informed consent for the Study

Exclusion Criteria:

* Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of ST-1891 or levothyroxine
* Female patients who are pregnant or are breastfeeding starting 30 days prior to Screening
* Anticipated initiation or change in concomitant medications
* Concomitant use of prohibited medications
* Currently participating in another clinical study or have received active treatment with an investigational drug within 30 days or 5 half-lives of the investigational drug of Screening, whichever is longer
Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy

This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have stable coronary artery disease undergoing elective PCI.
* Female subjects not of child-bearing potential.
* Absence of ST segment depression \>1.0 mm and absence of ST elevation \>1.0 mm in any lead on the baseline 12-lead ECG.
* subjects with CK-MB and troponin-T levels lower than the upper limit of normal.
* Subjects free of acute injuries or illnesses.

Exclusion Criteria:

* Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease.
* Subjects who had had an MI within 14 days prior to the PCI procedure.
* Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD).
* Subjects with history of TIA/stroke within 90 days or any intracranial bleed.
* Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal.
* Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements.
* Subjects with a history of alcohol or drug abuse.
* Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
* Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct.
* Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results.
* Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.
Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19

CLARITY 2.0 is an investigator-initiated trial that will evaluate the safety and efficacy of dual treatment with repagermanium, a CCR2 antagonist, and candesartan, an ARB, in patients hospitalised with COVID-19 disease.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged ≥ 18 years (maximum 65 years old in India).
2. Laboratory-confirmed diagnosis of SARS-CoV-2 infection within 10 days prior to randomisation. (Confirmation must be through Reverse Transcription Polymerase Chain Reaction \[RT-PCR\] method)
3. Intended for hospital admission for management of COVID-19.
4. Patients with moderate (respiratory rate of ≥ 24/minute or SPO2: 90% to ≤ 93% on room air) or severe (respiratory rate of ≥ 30/minute or SPO2: \<90% on room air) COVID-19.
5. Systolic Blood Pressure (SBP) ≥ 120 mmHg OR SBP ≥ 115 mmHg and currently treated with a non-RAASi BP lowering agent that can be ceased.
6. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
7. Documented informed consent.

Exclusion Criteria:

1. Currently treated with an ACEi, ARB or aldosterone antagonist, aliskiren, or ARNi
2. Intolerance of ARBs
3. Serum potassium \>5.5 mmol/L
4. An estimated Glomerular Filtration Rate (eGFR) \<30ml/min/1.732m
5. Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15)
6. Pregnancy, lactation, or inadequate contraception.
7. Participation in a study of a novel investigational product within 28 days prior to randomisation.
8. Plans to participate in another study of a novel investigational product during this study.
Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial

This is a future-proof and randomized controlled clinical study on the clinical efficacy of graphene photothermal adjuvant therapy in Corona Virus Disease 2019(COVID-19) patients with mild symptoms. The objective is to examine the effect of graphene photothermal adjuvant therapy on the time line for such Corona Virus Disease 2019 patients to achieve a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid test result, and their duration of disease. Patients who meet study criteria will be randomized into the Grapheme adjuvant therapy combined with conventional therapy group (treatment group) and the conventional therapy only group (control group). Contrasted to the control groups, the treatment groups will undergo 30-min of graphene adjuvant therapy every day for 7 d.

Following enrollment, patients will be randomized into treatment or control groups. All groups will receive the same conventional therapy.

In addition, treatment groups will undergo Graphene adjuvant therapy 30 minutes per day for 7 d.

Upon completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for mild COVID-19.
* Patients aged 18-60 years (inclusive).
* No later than 48 h after testing positive and the onset of clinical symptoms
* Sign informed consent form.

Exclusion Criteria:

* Severe or critically patients with COVID-19.
* Resting heart rate over 120 beats per minute.
* Coronary heart disease patients with acute cardiac insufficiency.
* Acute exacerbation of chronic obstructive pulmonary disease（COPD）.
* Uncontrolled hypertension \[resting systolic blood pressure(SBP) more than 180 mmHg and diastolic blood pressure(DBP) more than 90 mmHg\]; uncontrolled diabetes(Random Plasma Glucose, RPG\>16.7mmol/L, HbA1C\>7.0%)
* Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases.
* Pregnant or menstruating woman.
* Known or suspected history of active tuberculosis or extrapulmonary tuberculosis, patients with brucellosis, pneumonia-related illness from other causes
* COVID-19 patients for the second or more times
* Those who cannot cooperate due to various reasons
* Body temperature: more than 38℃.
The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms (BY1023/NL511)

The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Outpatients of at least 18 years of age
* History of GERD-related symptoms of at least 6 months prior to baseline visit
* Endoscopically-confirmed GERD or non-erosive GERD

Exclusion Criteria:

* Zollinger-Ellison syndrome or other gastric hypersecretory condition
* Acute peptic ulcer and/or ulcer complications
* Pyloric stenosis
* Severe or unstable cardiovascular, pulmonary, and/or endocrine disease
* Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential
* Intake of any medication for the purpose of eradication of Helicobacter pylori (H. pylori) within the last 28 days prior to study start
* Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs including cyclooxygenase-2 (COX-2) inhibitors for more than 3 consecutive days within the last 28 days prior to study start; with the exception of acetylsalicylic acid not more than 150 mg per day
Process of Regulation in Addictions: Vulnerability Emotional Factors to Craving

The aim of this study is to have a better understanding of the relationship between self-controle difficulties (and more specifically the inhibition deficit in impulsivity), emotional regulation disorders such as alexithymia and craving.This study will be the first in France to specify the interactions between self-regulkation processes dysfunctions and emotional dysfunctions in craving.

The main objective is to measure the level of cocaine craving, 6 months after the end of their detoxification treatment (outpatient or full hospitalization), in patients with a diagnosis of moderate to severe dependence (DSM 5) to cocaine and co-addiction, or not, to alcohol and / or psychostimulants. To evaluate cocaïne craving,the questionnaire CCQ-Brief will be used.

Eligibility Criteria:
Inclusion Criteria:

* Patient, men or women between 18 and 60 years-old
* Patient with a diagnosis of moderate to severe dependence (DSM 5) to cocaine with or without co-addictions to alcohol or psychostimulant.
* Patient on day-hospitalisation or full hospitalisation
* Patient affiliated or beneficiary to a social security scheme.
* Patient having signed the free and informed consent.

Exclusion Criteria:

* Patient with psychiatric disorders psychosis type
* Patient with severe chronic somatic disease.
* Patient participating in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant, breastfeeding or parturient woman.
* Patient hospitalized without consent.
Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization

The investigators will conduct a randomized controlled trial that aims to compare the incidence of contrast-induced nephropathy between transradial- and transfemoral-access cardiac catheterization.

Cardiac catheterization is a medical procedure used to diagnose and treat heart conditions. Approaching the heart can be done by different access sites: via the femoral artery (transfemoral) or the radial artery (transradial). Transfemoral access (TFA) is the primary mode of arterial access. Several clinical trials have demonstrated the benefit of transradial over transfemoral approach. The primary advantage of transradial approach is a significant reduction of access-site complications. Chronic Kidney Disease (CKD) is a serious condition associated with premature mortality, decreased quality of life, and increased health-care expenditures. ). It is commonly found in patients with diabetes, hypertension, hyperlipidemia, coronary artery disease, or combinations of these risk factors. Coronary artery disease and CKD are often comorbid conditions seen in the cath lab. Cardiac catheterization is a mainstay of diagnosis and treatment for coronary artery disease and 58% of deaths in CKD are related to cardiovascular deaths. Patients with CKD and who undergo a cardiac catheterization are at risk for contrast-induced nephropathy (CIN) due to the dye used during the procedure.

The investigators will conduct a randomized controlled trial that aims to compare the incidence of CIN between transradial and transfemoral cardiac catheterization.

Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled to undergo non-emergent cardiac catheterization at University Medical Center Hospital, Lubbock, TX from January 2016 to January 2018. Emergent cardiac catheterizations will be defined as a catheterization scheduled \< 24 hours from a cardiac event.
2. Patients willing to be randomized to TFA or TRA procedure.
3. Patients signed and dated the informed consent agreeing to participate in the study.
4. Patients with chronic kidney disease, defined as eGFR = 15-59mL/min defined by the MDRD formula. (eGFR is a standard of care measurement for all patients undergoing coronary intervention.).
5. Patients ages 18-88 years old.

Exclusion Criteria:

1. Patients who have previously undergone a coronary artery bypass graft procedure.
2. Patients with prior catheterization within the last 5 years.
3. Women who are pregnant or expect to become pregnant. Pregnancy tests for women of childbearing potential (WOCHP) will be performed as standard of care.
4. Patients with a history of cardiogenic shock.
5. Children (under the age of 18).
6. Medical, geographical, or social factors making study participation impractical, i.e. documented noncompliance, unable to return for follow-ups and lab draws, etc.
7. A positive Allen's Test on the right radial artery.
8. Any condition preventing TRA or TFA access.
9. Contrast used within the previous 3 weeks.
10. Allergy to contrast dye.
11. Inability to successfully access the artery randomized to use.