cyrilzakka/clinical-trials huggingface dataset:
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension

The purpose of this study is to see if a combined pill of Angiotensin-converting enzyme (ACE) inhibitors (a medication that helps relax your veins and arteries to lower your blood pressure) with diuretics (sometimes called water pills, help rid your body of salt and water) will control blood pressure better than a different blood pressure medication of calcium channel blocker (lower your blood pressure by preventing calcium from entering the cells of your heart and arteries). Both medications are part of our usual care for high blood pressure after delivery.

In individuals with preeclampsia, persistent hypertension and edema result in part from the mobilization of up to 8 liters of fluid and sodium from the extravascular to intravascular space. The increased urinary sodium excretion on days 3-5 postpartum likely results from higher atrial natriuretic peptide concentrations in plasma and activation of the renin-angiotensin-aldosterone system. Adding diuretics for postpartum hypertension has been associated with better blood pressure control in some of the studies.

* CVD is the leading cause for mortality worldwide.
* Primary prevention is more effective than treating CVD.
* Pregnancy is often the 1st adult engagement with the healthcare system.
* Preeclampsia is a risk factor for long term CVD, even after controlling for mutual risk factors.
* CVD is the leading cause for pregnancy related mortality.
* There is no good data regarding the optimal medications to control blood pressure after delivery.
* ACE inhibitors play an important role in controlling blood pressure outside of pregnancy and there is extensive evidence to support their cardioprotective effects.
* The optimal use of diuretics in the postpartum in patients with preeclampsia, require further study and clarification to augment current management schemes.

Hypothesis: that in postpartum women with hypertensive disorders, oral combined Hydrochlorothiazide/Lisinopril will reduce postpartum hypertension at 7 days after delivery compared to usual care with calcium channel blockers.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum women at ≥ 18 years of age
* Postpartum diagnosis of persistent hypertension (2 measurements of Systolic BP ≥150 and/or diastolic BP ≥ 100 or systolic BP ≥140 and/or diastolic BP ≥ 90 for people with diabetes) requiring an oral medication based on the ACOG criteria or
* Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum requiring blood pressure medication in the postpartum
* Chronic hypertension requiring blood pressure medication postpartum

Exclusion Criteria:

* Urine output \< 30 cc/h prior to screening for eligibility
* Creatinine \> 1.4 during current admission
* End-stage renal disease
* Hypersensitivity to ACE inhibitors or sulfa drugs
* Idiopathic/hereditary angioedema
* Hyperkalemia (serum potassium \>5 mEq/L) during current admission
* Pulmonary edema
RF Ablation of Atrial Fibrillation

This is an early feasibility trial designed to demonstrate whether a new ablation device can be used safely and effectively in treating atrial fibrillation.

This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at a single study site

This study is intended to evaluate the safety and preliminary effectiveness of the RFMesh BAS for electrophysiological mapping and radiofrequency ablation in the region of the ostium of a targeted pulmonary vein in the treatment of drug refractory paroxysmal atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are between 18 \& 85 years of age.
2. Patients with a minimum of 2 episodes of symptomatic PAF within the last 6 months prior to baseline evaluation. At least one of these episodes must have been documented. Documentation may include electrocardiogram (ECG), trans telephonic monitoring (TTM), Holter monitoring (HM), or telemetry strip. Additional PAF episodes (i.e., verbal accounts from the patient) will be documented in the patient's study record.
3. Patients who have failed at least 1 class I or class III anti-arrhythmic medication regimen.
4. Patients with the ability to understand the requirements of the study, who have provided written informed consent and agreed to the study restrictions and to return for the required follow-up assessments.

Exclusion Criteria:

1. Any previous ablation of the left atrium (surgical or catheter based).
2. Permanent or persistent atrial fibrillation.
3. Recent myocardial infarction within 2 months
4. Currently unstable angina.
5. Any cardiac surgery during the previous 3 months.
6. Currently documented intracardiac thrombus by transesophageal echocardiography (TEE).
7. A left atrium \> 50mm in major dimension.
8. A common ostium larger than 25 mm in major axis or any individual pulmonary vein larger than 25 mm in major axis.
9. Permanent leads in or through the right atrium.
10. Clinically significant valvular heart disease or a replacement heart valve.
11. Congestive heart failure (NYHA classification III or IV).
12. An ejection fraction \<35%.
13. A contraindication to warfarin.
14. A contraindication to transseptal procedure.
15. Any cerebral ischemic event, including any transient ischemic attack (TIA), in the preceding 6 months.
16. Any known bleeding disorder.
17. Women who are known to be pregnant or nursing.
18. Uncontrolled hyperthyroidism.
19. Patients currently enrolled in any other clinical investigation.
20. Any other significant uncontrolled or unstable medical condition.
21. A life expectancy of less than one year.
22. Currently taking amiodarone or have taken amiodarone within 4 months prior to baseline evaluation.
Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

Managing iron deficiency is important for more than 1 billion individuals worldwide, to avoid blood transfusions, or excessive strain on vital organs that depend on iron-containing haemoglobin to deliver oxygen to the tissues. Iron deficiency is a particular problem for people with the inherited condition hereditary haemorrhagic telangiectasia (HHT). Their iron deficiency and anaemia results from blood losses, especially from the nose (nosebleeds, and they often need additional iron to replace that lost through bleeding.

Our goal is to stratify HHT patients into high/low absorbers of iron; to define what extra iron they need to adjust for their current and likely future blood losses; and to work out how to achieve this most safely for each individual to improve their later health.

We will test the hypothesis that informed assessment of iron intake and post absorption cellular profiles changes the recommendations for iron intake for HHT patients.

Relevant patients due to come to clinic or the programmed investigation unit will be offered the opportunity to participate in the study.

Up to 100 consenting individuals will

* have an additional 15 mls of supplementary research bloods taken
* receive a single tablet of ferrous sulphate 200mg
* fill in questionnaires that formally evaluate their nosebleed losses and dietary iron intake in the preceding 12 months
* have a second blood sample later that day (20 mls of blood)

The primary outcome measure is the change in serum iron levels post iron tablet.

Other outcome measures will include:

* Haematinic indices indicating whether their iron requirements have been met previously.
* Additional predicted iron intake requirements to adjust for haemorrhagic iron losses

Eligibility Criteria:
Inclusion Criteria:

* Hereditary haemorrhagic telangiectasia (HHT). Definite diagnosis of HHT by international criteria.
* No iron tablets or treatment taken on day of assessment
* Ability to provide informed consent.

Exclusion Criteria:

* Inability to provide informed consent
* Intercurrent infection or illness predicted to modify iron absorption.
* Needle phobia.
A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient, \>/= 18 years of age
* Diagnosis of Type 2 diabetes mellitus within 12 months prior to screening
* Drug-naïve (defined as no anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months at any time in the past)
* HbA1c \>/= 7% and \</= 9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
* Fasting plasma glucose \</= 13.3 mmol/L (\</= 240 mg/dL) at pre-randomization visit
* Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study

Exclusion Criteria:

* Pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
* Diagnosis or history of:

  1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
* Any previous treatment with thiazolidinedione or with a dual peroxisome proliferator activated receptor (PPAR) agonist
* Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (\>= 1 month) statin therapy
* Prior intolerance to fibrate
* Triglycerides (fasting) \> 4.5 mmol/L (\> 400 mg/dL) at screening or within 4 weeks prior to screening
* Clinically apparent liver disease
* Anemia at or within 4 weeks prior to screening
* Inadequate renal function
* Symptomatic congestive heart failure New York Heart Association (NYHA) Class II-IV at screening
* Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit
* Known macular edema at screening or prior to screening visit
* Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
* Uncontrolled hypertension
* History of active substance abuse (including alcohol) within the past 2 years
Screening for Pregnancy Related Pelvic Girdle Pain

To perform clinical manual pain provocation tests of the pelvic joints in pain free pregnant women early in pregnancy, follow them until delivery, and compare those who develop PPGP with those who don't.

One arm study:

Pregnant women are informed about the study at their first visit in Maternity care. Those that are interested in participating sign an informed consent, and book an appointment with a manual therapist. During the appointment five pain provocation tests are performed to the pelvic joints, and about 13 questions regarding previous low back pain, trauma to the pelvic, or pelvic pain during previous pregnancies, number of previous pregnancies, number of years with contraception, any presence of lactosis intolerance, profession, degree of physical exercises, gestational week, age, and BMI are asked by the therapist. Each participant is given a telephone call after delivery, to ask whether any pelvic pain ocurred or not, and whether sick-leave was necessary.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women before gestational week 20 without any ongoing symptoms of pain from their pelvic joints.

Exclusion Criteria:

* Fibromyalgia
* sick-leave
* working at home
* treatment of the pelvic joints during the pregnancy
Clinics and Epidemiology of Pituitary Diseases in Modena Area Population

This is an observational, longitudinal, single-center study.

The study is divided in two phases:

* FIRST PHASE (retrospective): registration of all patients affected by pituitary disorders followed at the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena
* SECOND PHASE (prospective): enrollment of all patients affected by pituitary disorders who attend the Unit of Endocrinology of the Azienda Ospedaliero-Universitaria of Modena.

An anonymized database will be created to collect the data of the patients. In particular, the data collected for each patient will include: personal data, data relating to pituitary pathology, symptoms at diagnosis, physical examination, radiological imaging, visual field data, data on surgical intervention, data on histological examination, biohumoral examinations, hormone tests, densitometric data, data on replacement therapies, medical therapies or other pharmacological therapies, data on comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* subjects affected by pituitary disorders who attended Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena

Exclusion Criteria:

* subjects under 18 years old
R-21 Colorectal Cancer Screening (CRCS) Pilot Trial

The goal of this study is to test patient education program for decision making about colorectal cancer (CRC) screening in community health centers.

Baseline Visit:

If you agree to take part in this study, you will complete a questionnaire that asks demographic questions (such as your age and sex) and questions about colorectal cancer. It should take about 10-15 minutes to complete.

You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. If you are in Group 1, you will view a colorectal cancer program. If you are in Group 2, you watch a program on Essential Hypertension.

You will watch the program on a laptop in the clinic. The program is about 30 minutes long. After you watch the program, you will complete a questionnaire that asks what you thought about the program and some questions about understanding medical information. It should take about 5-10 minutes to complete the questionnaire.

You will be called 1-3 weeks after your baseline visit to complete a questionnaire by phone. The call should last about 20-25 minutes. You will be asked if you discussed colorectal cancer screening tests with your doctor, your preferences for colorectal cancer screening tests, and if any colorectal cancer screening tests were ordered.

At Month 3, your medical record will be reviewed by the study staff.

Length of Study:

You will be off study after your medical record is reviewed at Month 3.

This is an investigational study.

Up to 180 participants (90 Hispanic and 90 African-American) will take part in this study. All participants will be enrolled from the Harris County Hospital District and Kelsey-Seybold outpatient clinics.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients
2. 49 -75 years of age
3. English-speaking African American or Spanish-speaking Hispanic patients (upon approval of spanish language arm)

Exclusion Criteria:

1. History of colorectal cancer
2. History of polyps
3. Any inflammatory bowel disease (IBD), e.g. Crohn's disease or ulcerative colitis
4. Family history of colorectal cancer in a first degree relative
5. Had fecal occult blood test (FOBT) in the past year, flexible sigmoidoscopy in the past 5 years or colonoscopy in the past 10 years
The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda

To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa

The BabySaver kit will be used for any delivery in which the baby requires resuscitation according to the hospital policy, national guidelines(Ministry of Health, 2016) and WHO policy(World Health Organization, 2014)

The target sample size for observation will be 30 babies requiring resuscitation at Mbale Regional Referral Hospital Delivery suite.

The researchers will observe midwives and mothers during the process of resuscitation. This will be a non-participant observation. The researchers will collect data on: demographics, the timing of cord clamping, time to establish ventilation, intervention provided on the kit, post-resuscitation temperature, need to move the baby to provide extra care, and notes of the ease of use or challenges experienced with the kit. The researchers will ask health workers for their views of the usability of the kit in comparison to the equipment in current use.

The researchers have developed a usability checklist to assess how health workers are using the BabySaver kit.

Eligibility Criteria:
Inclusion Criteria:

* As this is the first delivery suite to use the kit in a clinical setting, we will include only low-risk babies in this study. Every low-risk birth that will need neonatal resuscitation will be selected and observations made for the use of the BabySaver resuscitation kit.

Exclusion Criteria:

* High risk deliveries will be excluded, namely

  * babies born before 34 weeks' gestation,
  * babies with life threatening malformations or significant intrapartum asphyxia
A Trial of Strontium +/- Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer

This study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.

This study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma of the prostate
* life expectancy \> 3 months,
* symptomatic from bone metastases
* radiologic evidence of metastatic bone disease
* stable level of pain control
* \>18 years
* ability to complete assessments
* prior treatment (chemo) \> 4 weeks previous
* discontinued anti-androgens for \> 4 weeks

Exclusion Criteria:

* prior strontium therapy
* previous hemibody RT within 6 weeks
* previous cytotoxic chemotherapy within 4 weeks
* use of bisphosphonate medications within 4 weeks
* change in steroid dose within 4 weeks
* active uncontrolled infection
* impending or present spinal cord compression
* significant neurological disorder
* impending pathological fracture
* severe urinary incontinence
Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts

The goal of this clinical trial is to compare surgical treatment outcomes of odontogenic keratocysts (OKC) treated with enucleation and local application of Carnoy's solution or 5% 5-fluorouracil. The main questions it aims to answer are:

1. What is the recurrence rate of OKC treated with enucleation and local application of 5% 5-fluorouracil cream in the period of three and five years after the treatment
2. What is the recurrence rate of OKC treated with enucleation and local application of Carnoy's solution in the period of three and five years after the treatment
3. Is there a difference in the recurrence rate between these two groups
4. What is the frequency of sensitivity disorders in the innervation zone of inferior alveolar and infraorbital nerves in both groups

Participants will be assigned to one of two groups after Histopathological verification (HP verification).They will be treated with enucleation and local application of Carnoy's solution or 5% 5-fluorouracil depending on group. After surgical treatment they will be monitored in accordance to standard treatment protocols for patients with OKC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified OKC of the upper or lower jaw;
* Indicated surgical treatment of OKC

Exclusion Criteria:

* Hypersensitivity to 5-fluorouracil and Carnoy's solution;
* Pathological fracture of the jaw in OKC region.
* Nevoid basal cell carcinoma
Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers

The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when administered with alcohol and compare to administration with water.

Outcome: Pharmacokinetic parameters

Eligibility Criteria:
Main Inclusion Criteria:

* Body mass index (BMI) within the range of 20 to 33 kg/m2 and a minimum weight of at least 50 kg.
* Current alcohol users who are classified as moderate drinkers
* Able to abstain from alcohol during the 48 hour period preceding each study visit
* Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-Lead ECG, and laboratory evaluation

Main Exclusion Criteria:

* Intolerance towards alcohol
* History of allergy or hypersensitivity to opioids or related drugs or any excipients
* Any history of drug or alcohol dependence
* Clinically significant abnormalities on physical examination, medical history, 12-Lead ECG, vital signs, or laboratory values
* Gastrointestinal disease or constipation or other clinically significant gastrointestinal problems
Foot and Abdominal Massage Applied to After Colonoscopy

The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale

The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants meeting inclusion criteria were assigned to intervention and control groups using a random. Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale

Eligibility Criteria:
Inclusion Criteria:

* Being of 18 years of age and above
* Applying for colonoscopy for diagnosis and treatment,
* Being conscious and oriented to place, person and time,
* Having pain after the procedure,
* No communication barriers,
* Able to communicate in Turkish,
* Individuals who gave written consent to participate in the research were included in the study.

Exclusion Criteria:

* Having any psychiatric disease,
* Those who have previously had bowel resection or another bowel surgery,
* Those with colostomy and ileostomy,
* Those with percutaneous endoscopic gastrostomy,
* Those with Inflammatory Bowel Disease,
* Having a history of malignant intestinal obstruction in their health history,
* Diagnosed with colon cancer,
* Those with umbilical/abdominal hernia,
* Having an open wound in the abdominal and/or foot area,
* Those with active lower gastrointestinal system bleeding,
* Those with celiac disease,
* Patients with FMF disease were excluded from the study.