cyrilzakka/clinical-trials huggingface dataset:
To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

Administration of esomeprazole 40 mg to subjects who still had heartburn after receiving rabeprazole 20 mg once daily for 4 to 8 weeks will result in statistically significant improvement of heartburn after 8-week treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 20 years or more
* Documented history of reflux esophagitis verified by endoscopy in the past, including the grade of Los Angeles (LA) classification (Lundell LR et al 1999) before treatment
* Ongoing (until date of Visit 1) treatment with rabeprazole 20 mg, given once daily, for a period of 4 to 8 weeks. The subject must take Rabeprazole at least 4 days a week in the past 7 days prior to Visit 1.
* Persisting symptoms of heartburn during the past 7 days prior to Visit 1, judged by the investigator(s) as follows: At least 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities) OR At least 4 days with symptoms including mild ones (i.e. awareness of sign or symptom, but easily tolerated).
* The subject needs to be able to understand and read the official languages of the country.

Exclusion Criteria:

* Use of other PPIs and/or H2RA during rabeprazole treatment
* Previous use of esomeprazole 40 mg during the 12 weeks before enrolment
* Current or historical evidence of gastrointestinal pathology
* History, signs or symptoms of clinically significant or uncontrolled cardiovascular, pulmonary, renal, endocrine, hematologic, neurologic, psychiatric pancreatic or hepatic disease as judged by the investigator to interfere with the conduct of the study, the interpretation of study results, subject compliance, or the health of the subject during the study.
* Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or pyloroplasty, hiatus hernia surgery or fundoplication. Note: endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection or simple suturing of an ulcer are not exclusion criteria.
A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.

To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who voluntarily participate in this study and sign informed consent form;
2. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
3. ECOG performance status of 0 or 1；
4. Expected survival \> 12 weeks;
5. The subject has at least one measurable lesion;
6. Normal function of major organs;
7. The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.

Exclusion Criteria:

1. Subjects who have received prescribed treatment previously;
2. Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
3. Subjects with known central nervous system metastasis and multiple bone metastasis;
4. Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks;
5. Have a history of other malignant tumors within 5 years before signing the informed consent;
6. Subjects with prescribed cardiovascular diseases;
7. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
8. Had severe lung disease before randomization;
9. Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was \> grade 2, and other reversible toxicity was \> grade 1;
10. Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
11. Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
12. Subjects who are known to be allergic to any component of B013 or paclitaxel.
13. Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
14. Female subjects who are pregnant or breastfeeding;
15. Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.
Purify Antigen-specific B Cells From Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disease characterized by the presence of autoantibodies directed against citrullinated proteins, called ACPAs. These antibodies are very specific to RA, and the severity of the disease is closely correlated with the level of these ACPAs, even though they appear much earlier than the clinical signs. Current treatments by biotherapies are effective but only treat the inflammatory symptoms of the disease or, on the contrary, induce a global immunosuppression with a depletion of all B lymphocytes.

Contrary to the current approaches, the CURE RA project proposes a double innovative character:

* The project aims at specifically destroying B lymphocytes expressing / or secreting ACPAs for a more specific approach to RA, without inducing immunosuppression.
* The new therapeutic molecule is entirely original and has no equivalent at present, it uses the target antigens of autoantibodies, the citrullinated peptides, as tools to destroy the pathogenic B cells that express/produce these autoantibodies.


Eligibility Criteria:
Inclusion criteria:

- Antibodies anti-CCP + (ACPA +) \> 250 IU/mL

Exclusion criteria:

* Current or past Rituximab (Mabthera) treatment past (\< 9 months)
* Abatacept treatment
Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations

Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the general practitioner involvement (signature) and a more personalized communication in invitation letters to organized screening of breast, colorectal and cervical cancers.

The hypothesis on which this project is based is that communication is probably more effective if the "receiver" feels personally targeted by invitation letters (Dear Martin, I am writing ...) and if he knows "the issuer "(his general practitioner rather an unknown person).


Eligibility Criteria:
Inclusion Criteria:

* Living in Indre-et-Loire (french territorial division 37)
* Be affiliated to the following three health insurance companies: CPAM (Caisse Primaire d'Assurance Maladie), MSA (Mutualité Sociale Agricole), or RSI (Régime social des Indépendants)
* Having declared (to health insurance company) an attending physician who has given its written consent to participate in the study
* Present no exclusion criterion to cancer screening ( for each one)
* Be old from 50 to 74 years (breast and colorectal cancer) or from 25 to 65 years (cervical cancer)

Exclusion Criteria:
Traditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia

The goal of this type of clinical trial is to learn about symptomatic patients with post-COVID-19 parenchymal lung abnormalities. The main questions it aims to answer are: the efficacy and safety of low-dose dexamethasone or traditional Chinese medicine in symptomatic patients with post-COVID-19 parenchymal lung abnormalities.

Participants will be divided into three parallel groups：controlled group with conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc. dexamethasone group: dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine. Chinese medicine group: Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COVID-19 pneumonia；
* 3 to 8 weeks after the onset of the first symptoms of COVID-19 infection;
* Modified Medical Research Council (mMRC) score ⩾2 or hypoxemia;
* Imaging severity assessment of pneumonia: CT severity scores (CTSS):≥5；
* Signed the informed consent.

Exclusion Criteria:

* Participants still admitted to intensive care unit at the time of enrollment;
* Known prior structural lung disease, including pulmonary fibrosis, severe COPD, severe bronchiectasis, and lung destruction;
* Taking glucocorticoids or immunosuppressants because of other chronic diseases;
* Contraindications of glucocorticoid;
* Heart failure(NYHA III or IV);
* Participants with renal replacement therapy;
* Psychiatric disorders or cognitive impairments;
* The expected survival time is less than six months due to diseases other than COVID-19 pneumonia.
Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)

This study will gather information on the safety and efficacy of patients with rheumatoid arthritis (RA) who are starting treatment with infliximab for the first time. Patients will be treated in the usual manner according to local guidelines and normal clinical practice.

Local patients, diagnosed with RA at the National Institute of Rheumatic Diseases, Piestany, Slovakia, can participate, if their physicians have decided to treat the patient with infliximab. Registration for the trial will be done on a voluntary basis.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have been given patient leaflet,
* Subject must not have ever received infliximab at the time of registration,
* Subject must be a good candidate for infliximab as per Summary of Product Characteristics
* Subject must sign the approved consent form

Exclusion Criteria:

* None
LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study

LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..

LUXSOL Topical Cream is a copper containing topical cream indicated for the treatment of bacterial vaginosis (BV). The study is an open-label, randomized, controlled study comparing LUXSOL Cream to Metrogel in patients with a diagnosis of BV. The investigational product or the comparator product will be self-administered by the patient for 10 consecutive nights. A successful patient outcome is cured BV at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Subject agrees to participate and signs informed consent
* Female age 18 or older
* Subject has clinical BV with 4 of 4 Amsel's criteria
* Off-white (milky or gray), thin, adherent, homogenous discharge with minimal or absent pruritus and inflammation of the vulva and vagina
* Presence of 'clue cells' \>/=20% of the total epithelial cells on microscopic examination of the saline 'wet mount.'
* Virginal secretion pH of \>4.5
* A fishy odor of the vaginal discharge with the addition of a drop of 10% KOH (i.e. a positive 'whiff test')
* Subject agrees to refrain from use of douches, intravaginal products for treatment period
* Subject agrees to refrain from taking oral or intravaginal antibiotics or antifungal agents during entire study period
* Subject agrees to refrain from vaginal intercourse during treatment period.

Exclusion Criteria:

* Subject has another infectious or noninfectious cause of vulvovaginitis
* Subject has another vaginal or vulvar condition that would confound the determination of study endpoints.
* Subject has received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days prior to enrollment.
* Subject is under treatment for cervical intra-epithelial neoplasia or cervical carcinoma
* Subject is known to be HIV positive
* Subject has a positive pregnancy test
* Subject has any abnormal anatomy or pathology of the vagina
* Subject has untreated sexually transmitted disease
* Subject is currently having menstrual period or may have her period during treatment days.
* Subject's PAP smear \>/= to LSIL
* Subjects with known sensitivity or allergic reactions to copper or Metronidazole vaginal gel
* Subject has known Wilson's disease
A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression

The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine:

* How well NORA520 is tolerated and what side effects it may cause
* If NORA520 reduces depressive symptoms in subjects with severe PPD
* The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken
* In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days.


Eligibility Criteria:
Key Inclusion Criteria:

* Are willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits
* Are an adult female between 18 and 45 years of age, inclusive;
* Have either ceased lactating at Screening, or if still lactating or actively breastfeeding at Screening, agree to temporarily cease giving breastmilk to their infant(s) from just prior to first dose of study drug on Day 1 through Day 14;
* Have a negative pregnancy test at Screening and Day 1 (prior to dosing);
* Have had a depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery
* Are ≤9 months postpartum at Screening.

Key Exclusion Criteria:

* Have a history or current diagnosis or current treatment of bipolar disorder, schizophrenia, or schizoaffective disorder;
* Have had recorded treatment failure of ≥2 different antidepressant classes (e.g., SSRI, SNRI) in the current or previous episode;
* Are currently experiencing active psychosis per Investigator assessment, or are taking typical or atypical antipsychotic medication;
* Have a history of suicidal behavior within 2 years;
* Have a history or current diagnosis of sleep apnea or narcolepsy.
Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers

Primary objective:To investigate if BI 10773 affects the pharmacokinetics of ramipril and if ramipril affects the pharmacokinetics of BI 10773.


Eligibility Criteria:
Inclusion criteria:

1. healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions.
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

The purpose of this study is to confirm the efficacy and the safety of Avanafil 100mg, 200mg or placebo administered orally for 12 weeks in patients with erectile dysfunction. The efficacy is evaluated by IIEF, SEP Q2 and Q3 and GEAQ and the safety is evaluated by laboratory tests, vital signs, physical examination and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* male subjects aged 19 to 70 with history of erectile dysfunction for at least 6 months
* subjects have stable monogamous relationships
* their partners are free from pregnancy and lactation and well prevent conception
* subjects consented to participate in the clinical study in writing
* subjects attempted sexual intercourse at least 4 times in separate days during 4 weeks' free run-in period, and failure rate is over 50%

Exclusion Criteria:

* history of spinal cord injury or radical prostatectomy
* subjects whose penises are anatomically deformed
* erectile dysfunction due to neurogenic or endocrine cause
* subjects who have uncontrolled major psychiatric disorder and do not accept therapies or have significant neurological abnormalities
* history of cancer chemotherapy within 1 year
* subjects who are addicted to alcohol or have continuously misused dependent drugs
* subjects who have hepatic dysfunction(GOP,GPT ≥ 3xUNL) or renal dysfunctions(serum creatinine \> 2.0)
* subjects who have uncontrollable diabetes(FPG\>180)
* subjects sho have proliferative diabetic retinopathy
* history of stroke, transient ischemic attacks, myocardial infarction, heart failure that needs to be medically treated, unstable angina or fatal arrhythmia or coronary artery bypass graft within 6 months
* serious hypotension or uncontrollable severe hypertension
* hematological disorders that is likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia
* subjects who have retinitis pigmentosa
* subjects who suffered from serious GI bleeding disorder within 1 year
* subjects who took other PDE5 inhibitors or ED therapies within 2 weeks
* subjects who use non-concomitant medications(Nitrate/NO donors, Androgens, anti-androgen, trazodone, Anticoagulant,over-the-counter drugs known to inhibit the activity of CYP3A4)
* history of hypersensitivity to the PDE5 inhibitors or not responded to them
* subjects who have hypoactive sexual desire
* subjects who have no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period
* subjects who took other investigational products within 30 days before this clinical study
* subjects who are judged to be unsuitable to the clinical study by other reasons
Functional Applications of Hyperpolarized 129Xe MRI

The overall objectives of our study are to determine the capabilities of hyperpolarized 129Xe MRI to measure lung function and its potential to sensitively detect pulmonary disease and its progression in COPD. We hypothesize that measurement of alveolar surface area, septal thickness, and capillary transit time measured with hyperpolarized 129Xe will correlate better with quality of life measures in COPD subjects than traditional diagnostic measures such as spirometry and Computed Tomography.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-75

For Healthy nonsmoker subjects:

* No current physician diagnosed medical disease requiring active medication
* No smoking history, defined as less than 100 cigarettes smoked in a lifetime
* Normal spirometry: FEV1/FVC ≥ 0.70, FEV1 ≥ 80% predicted

For Subjects who have participated in the COPDGene Study

* Post-bronchodilator spirometry: FEV1 \> 40% predicted

Exclusion Criteria:

* MR contraindications: e.g., electrical implants such as cardiac pacemakers, ferromagnetic implants such as prostheses, claustrophobia
* Pregnancy or suspected pregnancy
* Use of continuous oxygen
* Use of antibiotics and/or systemic corticosteroids (new prescription or increased dose) for an exacerbation of lung disease or any lung infection in the past four weeks
* Uncontrolled cancer, as defined as ongoing radiation therapy, ongoing chemotherapy
* A heart attack in the past three months
A Study of Decreased Mental Function Associated With HIV

The purpose of this study is to compare pictures of the brain of HIV-infected people with memory problems before and after treatment with selegiline. Selegiline is the study drug received through A5090.

HIV patients generally develop memory problems late in the disease. This will be examined using noninvasive proton magnetic resonance spectroscopy (1H-MRS). The effect of the drug selegiline on memory problems also will be examined.

HIV-associated cognitive impairment generally develops during the later stages of the disease. This study proposes to non-invasively examine the pattern and extent of cerebral injury associated with HIV infection and its response to selegiline by using 1H-MRS. The following hypotheses will be tested: selegiline, a compound with antioxidant and anti-apoptotic properties, will reverse the metabolic abnormalities measured by 1H-MRS, and these changes will parallel the degree of improvement in cognitive and functional performance.

This is a substudy of ACTG A5090. The pattern and extent of cerebral injury associated with HIV infection and its response to selegiline are examined using a 1H-MRS. 1H-MRS evaluations are performed at screening and Week 24 (or at the time of premature discontinuation) of Step 1 of A5090. The screening MRS exams may only be performed once all A5090 screening evaluations (including the lumbar puncture) have been completed and it has been determined that the patient is eligible for A5090 study entry.

The screening MRS must be performed prior to A5090 study drug administration. The Week-24 MRS must be performed while the patient is still on blinded study drug.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are enrolled in ACTG protocol A5090.
* Meet the inclusion/exclusion criteria set forth for the Step 1 phase of AACTG protocol A5090.

Exclusion Criteria

Patients will not be eligible for this study if they have:

* Claustrophobia (unless sedation with lorazepam or zolpidem allows for safe performance of the MRS).
* Metallic implants/medical devices (e.g., skull implants or cardiac devices).
Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)

The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for the MVI 200 in women requiring cervical ripening and induction of labor.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent;
* Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
* Women aged 18 years or older;
* Candidate for pharmacologic induction of labor;
* Single, live vertex fetus;
* Baseline modified Bishop score ≤ 4;
* Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
* Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion Criteria:

* Women with hemoglobin level \< 10.0 grams per deciliter (g/dL) (confirmed within one week of study drug insertion);
* Women in active labor;
* Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
* Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
* Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
* Fetal malpresentation;
* Diagnosed congenital anomalies, not including polydactyly;
* Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
* Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
* Ruptured membranes ≥ 48 hours prior to the start of treatment;
* Suspected chorioamnionitis;
* Fever (oral or aural temperature \> 37.5°C);
* Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
* Known or suspected allergy to misoprostol, other prostaglandins or any of the excipients;
* Any condition urgently requiring delivery;
* Unable to comply with the protocol.