cyrilzakka/clinical-trials huggingface dataset:
Increasing Potassium Intake in Hypertensive Individuals

This study evaluates the safety of increasing dietary potassium intake in a hypertensive population that may be at risk for hyperkalemia.

The blood pressure lowering benefits of increasing dietary potassium (K⁺) are well known. As such dietary recommendations for hypertension focus on a diet rich in high K⁺ food sources such as fruits and vegetables. An important theme to be addressed is the safety of achieving high dietary K⁺ intake in hypertensive individuals who are also receiving medical therapy that might predispose to elevated serum K⁺ levels (hyperkalemia).

The purpose of this study was to assess the impact of aggressively increasing dietary K⁺ on serum K⁺ concentrations in hypertensive individuals with intact renal function medicated with RAAS blocking drugs. The investigators hypothesized that dietary K⁺ supplementation would not provoke hyperkalemia despite treatment with either an angiotensin converting enzyme (ACEi) or an angiotensin receptor blocker (ARB).

The investigators conducted an open controlled clinical trial in 20 hypertensive subjects with normal renal function who were randomized to a usual diet group (UD n=10), or a high potassium diet group (HKD, n= 10). Fruits and vegetables were used to increase potassium intake. All participants were on an ACEi or and ARB. Serum potassium concentration, 3- day food records and 24 Hour urine collections were completed at baseline and at the end of the 4-week study.

Eligibility Criteria:
Inclusion Criteria:

* Medically treated hypertension as diagnosed Hypertension was established by the participant's cardiologist or if recruited from the online community hypertension was self-reported and confirmed by study investigators based on participant's medical prescription.
* Treatment with an beta blocker, ACE inhibitor, or angiotensin receptor blocker without any adjustment over the previous 3 months
* K+ intake at baseline of less than 80 mmol/day (food diary of 24 hour food recall).

Exclusion Criteria:

* Patients with an episode of acute coronary syndrome, or revascularization within the previous 3 months will not be included.
* Serum K+ concentration 5.0 mmol/L
* Serum creatinine \> 130 mmol/L.
* Inability to provide informed consent.
VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women

The purpose of the study is to show that valsartan compared to atenolol has favorable effects on exercise capacity, quality of life, diastolic function and elevated blood pressure in hypertensive postmenopausal overweight women with impaired exercise tolerance despite normal left ventricular ejection fraction (LVEF).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) must be ≥ 27 and \< 35
* Symptoms of impaired exercise capacity (e.g. who report shortness of breath on exertion when questioned) reported at Visit 1 or patients who have a history of shortness of breath which improved under diuretic therapy
* LV ejection fraction must be \> 45% measured by echocardiography at Visit 2.
* Impaired exercise capacity measured by VO2max at Visit 4:

VO2max \>14 and \< 22 ml ⋅kg-1 ⋅min-1

Exclusion Criteria:

* Mean sitting diastolic blood pressure (MSDBP) ≥ 110 mmHg and/or Mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg
* LVEF ≤ 45 %
* Inability to completely discontinue all previous antihypertensive medications safely for the duration of the study
* Heavy smokers (\>20 cigarettes/day)
Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Hepatocellular Carcinoma

The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years;
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
3. Treatment-naïve primary HCC (consistent with the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis (18)) or initial recurrent HCC after radical resection without any postoperative anti-cancer treatment;
4. At least one measurable lesion in the liver on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST);
5. Presented with Cheng's type I/II/III PVTT;
6. Largest tumor size ≤ 10 cm, number of tumors ≤ 3, and remnant liver volume ≥ 50%;
7. Child-Pugh class A;
8. Adequate hematological, liver, renal function:

   1. hemoglobin concentration ≥ 90 g/L;
   2. neutrophil count ≥ 1.5×109/L;
   3. platelet count ≥ 60×109/L;
   4. AST and ALT ≤ 3×upper limit of normal (ULN)
   5. total bilirubin ≤ 1.5×ULN;
   6. serum creatinine ≤ 1.5×ULN;
   7. serum albumin concentration ≥ 30 g/L;
9. Life expectancy of at least 3 months.

Exclusion Criteria:

1. Tumor invasion of the superior mesenteric vein or bile ducts;
2. Infiltrative HCC;
3. Allergic to research reagents;
4. With other malignancies within 5 years;
5. With poorly controlled hypertension;
6. A past medical history of hepatic decompensation, such as hepatic encephalopathy, refractory ascites, and esophageal or gastric variceal bleeding;
7. A history of autoimmune disease;
8. Active infection requiring systemic treatments;
9. Severe bleeding;
10. With diseases needing daily non-steroidal anti-inflammatory drug (NSAID) therapy;
11. With other severe comorbidities.
Trial of High-dose Urso in Primary Sclerosing Cholangitis

This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.


Eligibility Criteria:
* Chronic cholestatic disease of at least six months' duration.
* Serum alkaline phosphatase at least 1 ½ times the upper limits of normal.
* Retrograde, operative, percutaneous, or magnetic resonance cholangiography demonstrating intrahepatic and/or extrahepatic biliary duct obstruction, beading, or narrowing consistent with PSC within one year of the study entry.
* Liver biopsy in the previous one year which is available for review and compatible with the diagnosis of PSC. Compatible biopsy features include fibrous cholangitis, ductopenia with periportal inflammation and biliary fibrosis.
The Effects of Dance for Breast Cancer Patients Undergoing Surgical Treatment

The goal of this non randomized clinical trial, with pre- and post-intervention evaluation, longitudinal, with prospective data collection is to evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment.

The hypothesis is that dance will promote improvements in range of motion, strength, fatigue, functionality, pain and quality of life for breast cancer patients undergoing surgical treatment. Objectives: To evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment on: shoulder range of, overall muscle strength, fatigue, respiratory muscle strength, functionality, pain and quality of life. Method: This is a non-randomized randomized clinical trial, with pre- and post-intervention evaluation, prospective data collection. The following will be used for pre-intervention assessment: goniometry, dynamometry, manovacuometry, 6-minute walk test, fatigue and quality of life questionnaire, and quality of life questionnaire, as well as a pain assessment scale. After 16 weeks, the same variables will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with breast cancer
* undergone surgical resection
* after medical referral for physiotherapy
* and physiotherapeutic assessment

Exclusion Criteria:

* patients with another previous oncological diagnosis
* previous neuromuscular diseases
* patients who do not agree to take part in the study
* or the impossibility of carrying out the muscle strength assessment and/or other assessments
Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.


Eligibility Criteria:
* neonates born at gestational age of 35 weeks or greater
* neonates aged 0 to 14 days
* prenatally exposed to opioids
* severe NAS defined as 2 consecutive modified Finnegan Scores (MFS) \> or = 9

Exclusion Criteria:

* \< 35 weeks gestational age
* Intrauterine growth retardation defined as \<5%tile of gestational age
* postnatal treatment with barbiturates or benzodiazepines,
* major congenital anomalies
* major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications.
* breastfed infants
Mirror Box Therapy As a Treatment Option for Functional Movement Disorders

The purpose of this study is to investigate the potential of using mirror box therapy as a therapeutic technique amongst patients with functional movement disorders. It is hypothesized that a brief, single, in-office mirror therapy session will lead to a noticeable decrease in FMD-related involuntary movements.

Patients diagnosed with Functional Movement Disorder presenting with a unilateral or asymmetrical bilateral hand tremor will be asked to participate in a series of hand exercises with and without a mirror box. The severity of the tremor will be rated subjectively by the subject and objectively by the neurologist after hand exercises with and without the mirror box.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with functional movement disorder by a fellowship trained movement disorders neurologist, presenting predominantly with unilateral or asymmetrical bilateral involuntary movement in the upper extremity
2. In patients with bilateral involuntary movements, the symptoms in one arm must be minimal

Exclusion Criteria:

1. Patients with moderate to severe involuntary movement in both arms
2. Significant cognitive impairment that prevents proper informed consent
3. Severe involuntary movement that interferes with the use of the apparatus
4. Patients with hemiparesis or the loss of one arm due to various reasons (e.g. amputations, birth defects, etc.
Efficacy and Safety of Sipjeondaebo-tang on Korean Patients With Cold Hypersensitivity in the Hands and Feet (SDT)

Gachon University, Gil Oriental Medicine Center


Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged 19 to 59 years have a complaint of CHH.
* Patients must include at least one or more of the following symptoms:
* Those who have the symptoms of CHH in normal temperature which most individuals feel no cold;
* Those who have the symptoms of extremely cold hands in cold temperature exposure;
* Those who are on the return to a warmer environment, the symptoms of cold hands is not completely rewarmed;
* Those who have 4 cm or greater of VAS CHH score;
* A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
* Those who can comply with all study-related procedures, medications, and evaluations;
* Given a written informed consent form.

Exclusion Criteria:

* Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;
* Those who have one or more finger gangrene or ulceration;
* Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;
* Those who are diagnosed by autoimmune disease or have a positive ANA test result;
* Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests;
* Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;
* Those who are diagnosed with diabetes;
* Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc;
* Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL);
* Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious mental illness;
* Those who are Diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin (Hgb) level less than 7g/dL, hematocrit (Hct) level less than 26%, white blood cell (WBC) level greater than 11,000/mm3); Those whose systolic blood pressure (SBP) 180mmHg or diastolic blood pressure (DBP) is greater than 100 mmHg based on average value of at least 2 measurements;
* Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on;
* Those who are addicted to alcohol or drugs;
* Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;
* Those who are diagnosed with malignant tumor
* Those who are currently participated in other clinical trials;
* Those who are able to understand and speak Korean;
* Those who are judged to be inappropriate for the clinical study by the researchers.
Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital

Background: In type 2 diabetes mellitus patients, an acute coronary event (ACE) may result in a decreased quality of life and increased distress. According to the American Diabetes Association, transition from the acute care setting is a high-risk time for all patients, but tailored support specific to diabetes is scarce in that period. The investigators developed an intervention by a diabetes nurse to help diabetic patients reduce distress after their first ACE. The intervention is based on Bandura's Social Cognitive Theory, Leventhal's Common Sense Model, and on results of focus groups which were conducted to define the needs and wishes of type 2 diabetes patients and their partners regarding professional support after an ACE. The aim of this study is to evaluate the effectiveness of the intervention to reduce distress. The hypothesis is that patients who receive the intervention will have less diabetes related distress compared to the control group.

Methods/Design: Randomized controlled trial. Patients will be recruited directly after discharge from hospital. A diabetes nurse will visit the patients in the intervention group (n = 100) within three weeks after discharge from hospital, two weeks later and two months later. The control group (n = 100) will receive a telephone consultation. The primary outcome is diabetes related distress, measured with the Problem Areas in Diabetes questionnaire (PAID). Secondary outcomes are quality of life, anxiety, depression, HbA1c, blood pressure and lipids. Mediating variables are self-management, self-efficacy and illness representations. Variables will be measured with questionnaires directly after discharge from hospital and five months later. Biomedical variables will be obtained from the records from the primary care physician and the hospital. Differences between groups in change over time will be analyzed according to the intention-to-treat principle.

Discussion: Type 2 diabetes patients who experience a first ACE need tailored support after discharge from the hospital. This trial will provide evidence of the effectiveness of a supportive intervention to reduce distress in these patients.

See citation design paper

Eligibility Criteria:
Inclusion Criteria:

* History of type 2 diabetes (\>1 year)
* Discharged from the hospital after a first acute coronary event defined as a Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) procedure or Percutaneous Transluminal Coronary Angioplasty (PTCA)
* Sufficient knowledge of the Dutch language

Exclusion Criteria:

* A serious illness or condition which will prevent full participation
* Not able to fill in questionnaires
A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.

This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years.

This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation.

Eligibility Criteria:
Inclusion Criteria:

* Participant in the earlier Phase 3 Seasonique clinical trial

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition?

In neonates with recent small bowel resection or congenital bowel anomalies (gastroschisis or omphalocele), does an elemental formula as compared to a partially hydrolyzed formula allowed the infant to wean off Total Parenteral Nutrition (TPN) earlier?

Neonates with short bowel syndrome (SBS) due to recent small bowel resection or congenital bowel anomalies (gastroschisis or omphalocele) can have inability to adequately digest and absorb enteral feedings resulting in prolonged Parenteral Nutrition (PN) dependence for nutrition and growth. Prolonged PN dependence can result in Parenteral Nutrition Associated Liver Disease (PNALD) and intestinal failure requiring small bowel or small bowel/liver transplantation for survival.

After bowel resection, the bowel has an ability to compensate for significant loss by going through a process called intestinal adaptation. Enteral feeding is the key factor for initiating and maintaining the adaptation of the intestine.

Whole protein formulas or partially hydrolyzed formulas provide either the full protein or dipeptides/tripeptides respectively, and are thought to confer the best benefit in inducing intestinal adaptation and increasing paracrine stimulation. However, in small studies of adults and children with SBS,an amino acid based (elemental) formula demonstrated improved feeding tolerance and ability to wean off TPN. In a small study, babies fed breast milk or elemental formula appeared to have shorter duration of TPN.

This is a randomized, blinded clinical trial to determine if elemental formula, Elecare® (vs. partially hydrolyzed formula, Pregestimil®) is better tolerated and allows a higher proportion of neonates with small bowel resection or congenital bowel anomalies to successfully wean off TPN.

Eligibility Criteria:
Inclusion Criteria:

* Term or pre-term neonates with either surgical resection of the small bowel or congenital bowel anomalies (gastroschisis, omphalocele) unable to tolerate 90kcal/kg/day of enteral feedings by 1 month of age

Exclusion Criteria:

* Term or preterm neonates with NEC totalis,
* Inborn Errors of Metabolism, or
* Known or suspected congenital syndromes
Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth

Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.

children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* nonvital immature permanent teeth as a consequence of trauma or dental caries
* nonvital permanent teeth with radiographic evidence of immature root end development
* clinically restorable teeth

Exclusion Criteria:

* immature nonvital permanent teeth presenting with signs/symptoms of internal/external resorption, moderate to severe mobility, periodontal bone loss
* Immature nonvital permanent teeth associated with developmental abnormalities.
* Patients with a history of systemically debilitating diseases
* unrestorable remaining crown structure
Surgical Appendiceal Stump Closure - a Comparison Between Surgical Appendiceal Base Closure Methods, and Appendiceal Stump Complications.

comparing the rate and severity of postoperative complication after LA in regards of different appendiceal stump closure techniques. Data regarding different operative and postoperative parameters was collected from all appendectomies performed in a single medical center in Israel during the years 2010-2020.

To date, laparoscopic appendectomy (LA) is still the most common surgical procedure done in an acute setting \[1,2\]. Most patients presenting to the ER with acute appendicitis, will undergo an appendectomy in the same hospital admission \[3\]. The widely practiced technique for LA, is the placement of access trocars in a proper triangulation, insufflation of the abdomen to create a pneumoperitoneum, dissecting through the mesoappendix with electrothermal devices to expose the appendiceal base, appendiceal stump closure and appendiceal resection, and finally extraction of the resected appendix \[4\].

There are multiple techniques to close and secure the appendiceal stump. The use of staples, clips and prepared surgical knots such as the ENDOLOOP with PDS suture is widely in use. Although requiring less manual surgical skill to use, the costs of staples and clips are higher than the prepared suture, and the use of larger trocars is obligatory \[4\].

Yet, data comparing the postoperative efficacy and safety of these appendiceal stump closure techniques is scarce.

The aim of this study is to compare the postoperative efficacy and safety of appendiceal stump closure techniques, and to assess their cost effectiveness.

This is a retrospective, single center study, comparing the rate and severity of postoperative complication after LA. Data regarding different operative and postoperative parameters was collected from all appendectomies performed in a single medical center in Israel during the years 2010-2020.

Eligibility Criteria:
Inclusion Criteria:

all patients over the age of 18, who underwent appendectomy between the years 2010-2020

Exclusion Criteria:

patients who did not undergo appendectomy patients who underwent appendectomy not using one of the accepted techniques do appendiceal stump closure