cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine

Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.control of blood pressure is of crucial importance to avoid maternal and fetal complications.Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE

Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.

Pre-eclampsia characterized by

* Rising blood pressure (BP ≥ 140/90 that occurs after 20 weeks of gestation in a woman with previously normal BP.
* . Proteinuria (≥300mg/24hr . This correlates with 30mg/dl or ≥1+ on urine dipstick)
* Edema control of blood pressure is of crucial importance to avoid maternal and fetal complications.

The pathophysiology of pre-eclampsia is most likely inadequate placentation, leading to endothelial dysfunction and reduced nitric oxide bioavailability. Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE

. Nitroglycerine, a nitric oxide donor with low oral bioavailability and a very short half-life, has a potent venodilator effect in low doses and affects arterial tone at high doses Labetalol is useful as it contains both selective, competitive, alpha1-adrenergic antagonism and non-selective, competitive, beta-adrenergic (B1 and B2) blocking activity in a single agent Nifedipine is a dihydropyridine calcium channel blocker. Its main uses are as an antianginal and antihypertensive

Eligibility Criteria:
Inclusion Criteria:

* The study will include 60 adult female patients ( 18 to 40 years old) with sever pre-eclampsia, who were being managed with MgSO4 loading and maintenance doses Severe hypertension was diagnosed by Systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥110 mmHg.

Mean arterial blood pressure ≥ 127 mmHg

Exclusion Criteria:

1. Patient refusal.
2. Eclampsia
3. Emenant eclampsia
4. HELLP syndrome
5. Chronic hypertension
6. Patients who have chronic obstructive pulmonary disease.
7. Patient with acute or chronic liver failure.
8. Known allergy to the study medications
Post-Marketing Safety Study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in the United States

The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.

This retrospective observational cohort study will use secondary, de-identified individual-level medical and pharmacy claims data provided by HealthVerity.

Eligibility Criteria:
Inclusion Criteria:

* Included in a health plan covered by HealthVerity database
* Covered by a health plan during at least 1 period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods), but not necessarily the full period.
* Demonstrate an AESI specified clean period of continuous baseline enrollment or activity before the period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods) during which the participant is covered.

Exclusion Criteria:

None
Buprenorphine Pharmacology Related to Addiction Treatment - 21

The purpose of this study is to examine if chronic buprenorphine administration will generate supersensitivity to opiates.


Eligibility Criteria:
Please contact site for information.
Comparative Evaluation of Pulpotomized Primary Molars With Mineral Trioxide Aggregate and New Endodonthic Cement

A new Endodontic Cement (NEC) is being compared with mineral trioxide aggregate in pulpotomy of primary molars.

Forty patient are selected randomly. Each patient has at least 2 teeth which require pulpotomy treatment. After removing of carious teeth by a low speed round bur and pulp exposure, roof of pulp chamber is removed completely by a high speed 008 fissure bur. Life tissues of pulp are removed by sharp excavator and rinsing with normal salin. Hemostat is achieved and cavity will be cleaned by 0.5% hypo chlorate solution. MTA or NEC material is mixed according to manufacturer instruction and will be placed in pulp chamber and over pulpal canal orifices for at least 1 mm. The light cure glass inomor is also mixed according to manufacturer instruction and is places over the A or B material and cured for 40 minutes. The treated tooth will be restored with a stainless steel crown or amalgam filling material.

Eligibility Criteria:
Inclusion Criteria:

* Vital pulp exposure of teeth with caries or trauma
* No clinical signs \& symptoms like pain,inflammation
* No radiographic signs \& symptoms like: internal resorption,external resorption, furcation involvement,pulp canal obliteration.
* The restorable tooth
* No dental treatment contraindication

Exclusion Criteria:

* Systemic diseases
* Existence of pain,inflammation or sinus tract
* No patient compliance
Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

The purpose of this study is to determine the maximal tolerated dose of idarubicin for chemoembolization of non resectable non metastatic hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is the fifth most common malignancy and the third most common cause of cancer-related death worldwide. Most of the patients are diagnosed at intermediate-advanced stage when the sole standard treatment is transarterial chemoembolization (TACE). In the literature, survival rates in TACE studies vary widely and finally, there is no suggestion for the best chemotherapeutic agent or the optimal treatment regimen.

We hypothesise that the use of idarubicin (the most cytotoxic drug on HCC cell lines) in DC Bead would enhance the efficacy of TACE. The primary objective of the study is to determine the maximal tolerated dose of idarubicin in DC Bead for chemoembolization of non resectable non metastatic hepatocellular carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Hepatocellular carcinoma cytologically or histologically proved or diagnosed according the criteria of the American Association for the Study of Liver Diseases(AASLD 2005)
* Three nodules maximum (unilobar disease without limitation in the number of nodules; 3 maximum nodules if bilobar disease \[satellite nodules \<1cm not included in the total sum\])
* Child-Pugh score A or B7
* ECOG Performance Status \< 2
* Platelet count \> 50,000/µl and absolute neutrophil count (ANC) \>1,000/µl
* Serum creatinine \< 150 µmol/l
* Resting ejection fraction \> 50% (echocardiography or isotopic method)
* Age \> 18 years
* Signed written informed consent

Exclusion Criteria:

* Patients eligible for surgical resection or hepatic transplantation or radiofrequency ablation
* Extrahepatic metastases
* Known gastrointestinal bleeding up to 30 days before study entry
* Patients with anticoagulant treatment
* Evidence of portal vein thrombosis
* Pregnancy
* Clinically serious infection
* Known hypersensitivity to anthracyclines
* Known hypersensitivity to contrast medium
Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars

This study aim to assess the efficacy of Er-YAG laser 2940nm and PRP as a single line of treatment in comparison with combined treatment in atrophic post acne scars.


Eligibility Criteria:
Inclusion Criteria:

* patients with atrophic post acne scars classified on the basis of Goodman and Baron's Qualitative classification, no active acne lesions and patients with atrophic scars only

Exclusion Criteria:

* patients with positive history of keloidal tendency, positive history of bleeding tendency, platelet disorder, patients with any acute infection on face like, herpes, folliculitis, patients with HIV, HBsAg, patients with a history of autoimmune diseases or patients on immunosuppressive drugs.
Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus

Examination of the effect of Linagliptin versus placebo on diastolic function in patients with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic echocardiography.

Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be investigated.

Treatment:

The Patients will receive Linagliptin 5 mg QD or placebo for a period of 6 months.

The echocardiography and 24h RR measurement will be performed at baseline and 6 months after initiation of the therapy.

The blood chemistry (Glucose, HbA1c, BNP) will be evaluated at baseline as well as 3 and 6 months after initiation of the therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetes mellitus Type 2
2. Age \> 50 years
3. HbA1c \> 7%
4. Left ventricular diastolic dysfunction determined by echocardiography as average E/é ≥13 or average E/é≥8 and LA volume ≥34ml/m2
5. Stable anti-diabetic medication for the last 6 weeks which should include a maximal tolerated dose of metformin (unless contraindication or intolerance to metformin does exist).
6. Indication to increase anti-diabetic medication as judged by the investigator
7. Written informed consent prior to study participation

Exclusion Criteria:

1. Diabetes mellitus type 1
2. Echocardiography:

   * decreased left ventricular systolic function, ejection fraction (EF) \<45%
   * regional wall motion abnormalities
   * hypertrophic cardiomyopathy (septum \>15mm)
   * severe valvular dysfunction
3. Uncontrolled hypertension
4. Atrial fibrillation
5. Obstructive sleep apnea syndrome
6. Use of DPP-4 Inhibitor (Dipeptidyl-peptidase IV Inhibitor), GLP 1 agonists, Thiazolindinedione
7. Kidney disease CKD 4 and more (GFR \< 30 ml/min/1.73)
8. Liver disease (ALT or AST \> 3 times the upper limit of norm) or known liver cirrhosis
9. Active malignant disease
10. HbA1c \> 8.5%
11. Recent (\<3 months) clinically significant coronary or cerebral vascular event
12. Pregnant females as determined by positive \[serum or urine\] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
13. Lactating females
14. The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
15. The subject received an investigational drug within 30 days prior to inclusion into this study
16. The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study
17. The subject is unwilling or unable to follow the procedures outlined in the protocol
18. The subject is mentally or legally incapacitated
Smoking-cessation: A Spanish-Language Clinical Trial

The purpose of this study is to develop and test a series of culturally relevant and appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and remaining smoke-free.

Study Aim 1: To transcreate the existing English-language 10 "Stop Smoking for Good" booklets and accompanying 9 supportive "My Story" pamphlets into a series of culturally relevant and acceptable materials for Spanish-speaking smokers who prefer to receive health information in Spanish. The adaptation of the intervention materials will be based upon the findings from a systematic formative evaluation employing a heterogeneous group of Hispanic/Latino smokers representing diverse subcultural groups.

Study Aim 2: To test the efficacy of the self-help intervention developed in Study I among Spanish-speaking smokers in a randomized controlled trial. Participants (500) will be randomized to receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention or usual care (UC) comprising an existing booklet from NCI. Investigators hypothesize SS-SP will produce higher abstinence rates than UC through 24 months.

Secondary Aim: Test moderator variables to improve targeting the intervention. Moderator analyses will be exploratory, without strong a priori hypotheses.

Eligibility Criteria:
Inclusion Criteria:

* All Except Study I; Phase I Focus Group: monolingual Spanish, or bilingual Spanish-English and prefer receiving educational health materials in Spanish.
* Study I; Phase I Focus Group Only: Able to speak and read in English and Spanish.
* ≥ 1 year history of smoking
* Smoking ≥ 5 cigarettes per week
* Age ≥ 18 years
* Not currently enrolled in a face-to-face smoking cessation program
Efficacy of Group Intervention to Reduce Stress Symptoms

This research study will examine the usefulness of groups in reducing stress and helping individuals with HIV to stay healthy and avoid problems associated with sexually transmitted diseases. We hope to discover whether being in a group is effective in reducing stress-related symptoms and promoting healthy behaviors.

This is a risk reduction intervention for adults who are living with HIV, are experiencing trauma-related stress symptoms, and are at risk for HIV transmission. By first treating trauma symptoms, the effects of a skills-building HIV risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal, dissociation, and avoidance will be enhanced. This is based on a model the proposes trauma-related symptoms have direct effects on HIV risk behavior. Therefore, the successful treatment of trauma-related symptoms will facilitate HIV risk behavior change.

Eligibility Criteria:
Inclusion Criteria:Must be 18 years or older, must be HIV-positive, report engaging in behavior that could put them at risk for HIV transmission in the past three months, report experiencing one or more trauma-related symptoms within the past three months.

Exclusion Criteria:Exclusion criteria include the presence of gross cognitive impairment, dementia, acute psychosis, or severe physical impairment that would preclude adequate comprehension of assessment material and participation in small group intervention.
Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume

The objective of our study was to compare the efficiency of the right ULOD using thermal doses adjusted to ovarian volume (60 J/cm3) with the BLOD method at constant dose and to assess treatment efficiency.

The study included 96 infertile, clomiphene citrate-resistant women with polycystic ovary syndrome (PCOS), who underwent either unilateral or bilateral laparoscopic diathermy at the Clinical Hospital Split, Croatia. PCOS was diagnosed following the Rotterdam consensus criteria. In the ULOD group, we treated the right ovary with thermal dose of 60 J applied per one cubic centimeter of ovarian. In the comparator, BLOD group, all patients received 600 J per ovary. The follow-up period encompassed six menstrual cycles for all subjects.Sample size was based on the test of the primary hypothesis that ULOD treatment would result in a higher ovulation rate than BLOD. In our pilot study in 61 patients, ovulation rates were estimated to 44% in the BLOD arm and 69% in the ULOD arm. Assuming 5% significance and 80% power, we calculated that the minimal sample size for a one-sided test had to be 96 patients.

The aims of our prospective study:

1. Compare the efficiency of the right ULOD using thermal doses adjusted to ovarian volume (60 J/cm3) with the BLOD method at constant dose and to assess treatment efficiency and predict ovulatory response based on clinical parameters (right or left ovary and its volume) and received thermal doses.
2. Evidence the effects of ULOD using thermal doses adjusted to ovarian volume on endocrine (changes in androgen and AMH) and reproductive outcomes (ovulation rate) in clomiphene-resistant women with PCOS.
3. To determine whether unilateral laparoscopic ovarian drilling (ULOD) using thermal doses adjusted to ovarian volume diminishes ovarian reserve less than bilateral LOD (BLOD) using a fixed thermal dose

Eligibility Criteria:
PCOS was diagnosed following the Rotterdam consensus criteria

Inclusion Criteria:

* age between 25 and 35 years,
* BMI\<30 kg/m2,
* infertility period 1-3 years,
* normal partner's semen findings,
* LH≥10 or LH:FSH ratio ≥2,
* testosterone \>2.5 nmol/L,
* FAI\>4,
* normal oral glucose tolerance test (OGTT).

Exclusion Criteria:

* adrenal hyperplasia,
* thyroid disease,
* Cushing's syndrome,
* hyperprolactinemia,
* tumor-related androgen excess
A Study of the Long-term Safety of ABT-089 for Subjects With Mild-to-moderate Alzheimer's Disease Who Participated in the M06-876 Study

The purpose of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with mild-to-moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* The subject was randomized into Study M06-876 and completed the study.
* The subject must remain on the same dose of AChEI that was used during the M06-876 study.
* The subject is in general good health, as judged by the investigator

Exclusion Criteria:

* The subject is currently, or plans to participate in another experimental study during the course of this trial.
* The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.
The Maternal Well-Being Study

This project aims to understand the local feasibility and acceptability of MamaMeals (a home-delivered nutritious, postpartum meal delivery program) and MamaMatters (a moderated social media-based peer support group) among peripartum women who are eligible for federal supplemental nutrition assistance programs such as The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) or Supplemental Nutrition Assistance Program (SNAP). The investigators will conduct a prospective randomized controlled trial (RCT) of these two interventions among postpartum individuals. Analyses will be performed to determine the relative risk of postpartum depressive or anxiety symptoms (primary outcome) and overall well-being and maternal/infant health (secondary/exploratory outcomes) between groups. Findings from this pilot intervention study will inform a future, large RCT exploring the effectiveness of MamaMeals and/or MamaMatters on reducing postpartum mental health symptoms and cardiovascular morbidity among individuals with food insecurity during and after pregnancy.

1. To assess the local feasibility and acceptability of MamaMeals (home-delivered, nutritious meals) during the 4th trimester for mothers with peripartum food insecurity.
2. To explore perceptions about receiving a medically-tailored meal delivery intervention during the 4th trimester (MamaMeals) among a diverse sample of peripartum individuals with food insecurity (FI).
3. To assess through a randomized trial the potential efficacy of the MamaMeals (nutritious, home-delivered meals) and MamaMatters (ehealth postpartum support) interventions on peripartum mood disorders (primary outcome), postpartum cardiometabolic risk\* (exploratory outcome), maternal wellbeing (exploratory outcome), and infant health (exploratory outcome) during the first 12 months following delivery. Hypothesis: Individuals who receive the MamaMeals + MamaMatters interventions will have lower Edinburgh Postpartum Depression Scale (EPDS) scores throughout the first 12 weeks postpartum compared to groups receiving only one intervention or the control group.

Eligibility Criteria:
Inclusion Criteria:

* screen positive for food insecurity or qualify for any of the following governmental assistance programs Medicaid, WIC, SNAP, TANF,
* speak English,
* are between 20-40 completed weeks of pregnancy,
* are ages 18 years or older.

Exclusion Criteria:

* type 1 diabetes
* dietary contraindications (e.g., severe food allergy, or inflammatory bowel disease, celiac disease, chronic renal disease, bariatric surgery, short bowel syndrome)
* an active eating disorder (self-reported)
* hospitalization in the past 12 months for a mental health concern
* a history of postpartum psychosis
* Individuals with a history of being banned from any social media site will also be excluded.
Frameless Stereotactic Radiosurgery for Brain Metastases

The investigators plan to study high dose, single treatment radiation, using a plastic mask instead of a head frame that pins into a patient's skull. The investigators need to (1) quantify set-up accuracy and patient motion during radiation treatment and (2) ensure that without the head frame the tumour control rate and risk of complications are similar to our previous experience using the head frame.


Eligibility Criteria:
Inclusion Criteria:

* Patients with brain metastases from a biopsy-proven primary extra-cranial tumor site, excluding lymphoma, germ cell, and small cell lung carcinoma histologies.
* One to four metastases, and all lesions \< 3.5 cm in maximal diameter. Extracranial metastases is of minimal volume or stable with treatment. - Karnofsky performance status ≥ 70

Exclusion Criteria:

* None of the lesions is abutting or within critical neurological structures: \*brainstem

  * optic chiasm
  * eye, and optic nerve.
* The clearance between metastatic lesions and all critical structures must be at least 2 mm.
* Patients must not have leptomeningeal disease.
* Contraindications to imaging or radiation (e.g. pregnancy, elevated serum creatinine, allergy to contrast agents, severe claustrophobia, metal particles in the eye).