cyrilzakka/clinical-trials huggingface dataset:
Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection

To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.

The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan.

A total of 306 subjects are enrolled into this study.

H. pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive H. pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

* previous H. pylori-eradication therapy
* ingestion of antibiotics, bismuth, or proton pump inhibitors within the prior 4 weeks
* patients with allergic history to the medications used
* patients with previous gastric surgery
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* pregnant women
Effectiveness of Functional Pillow on Neck Pain, Disability, Quality of Sleep and Life

The purpose of this study is to investigate the effects of functional cervical pillow on inpatients with neck discomfort.

50 inpatients with neck discomfort(NRS\>4) will be randomly allocated to 2 groups. The experimental group was treated with functional cervical pillow and the control group was treated with general pillow. All applications of pillow were limited to 3-4 weeks. Primary outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to measure primary outcomes at baseline, 3 day, per weeks until the duration of admission. Satisfaction levels of the patient's current status, Neck disability Index(NDI) PSQI, EQ-5D will also be collected. The applicants will also get thru the diagnosis of range of motion by X-ray(flexion, neutral, extension of their neck position)

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to a Korean Medicine hospital
* Age between 18 and 69
* NRS score of \>4 on the day of the intervention
* Voluntary participation with written consent given to study consent form, including cervical x-ray

Exclusion Criteria:

* Diagnosis of serious disease(s) which are possible causes of neck pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda-equina compression, etc.
* Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
* Progressive neurologic deficit(s) or concurrent severe neurological symptoms
* Previously using any kind of functional pillow
Clinical Observation of Ciprofol for Anesthesia Induction

To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.

90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1 \~ 2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and BIS values at various time points during anesthesia induction were collected. At the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. The primary outcomes were the fluctuations in hemodynamic parameters during induction. The secondary outcome were adverse reactions, BIS values and changes of hepatic and renal functions during induction.

Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status Ⅰ-Ⅲ
2. Age over 65 years;
3. Body mass index (BMI) 20 \~ 30 kg/m2 ;
4. Elective noncardiac surgery;

Exclusion Criteria:

1. The patient or his/her family refused to participate in the clinical trial;
2. Severe heart, lung, liver or kidney dysfunction;
3. Expected difficult airway, requiring awake tracheal intubation;
4. Those who are allergic to the drugs used in this study;
5. Unsuccessful tracheal intubation twice;
6. Patients with mental illness or impaired consciousness;
Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)

This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl. In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not. It contains no active ingredients.


Eligibility Criteria:
Inclusion Criteria:- Males who have had ED for at least six months- Heterosexual relationship.- Males 18 and older. Exclusion Criteria:- Primary hypoactive sexual desire.- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.- Stable heterosexual relationship for \> 6 month- Other exclusion criteria apply according to the US Product Information
Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure \[msSBP\] ≥ 140 mmHg and \< 180 mmHg and/or mean sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 and \<110 mmHg).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients ≥ 18 years of age
* Patients with a diagnosis of mild to moderate hypertension at Visit 1
* All patients must have a msSBP ≥ 140 mmHg and \< 180 mmHg and/or msDBP ≥ 90 mmHg and \< 110 mmHg mmHg at Visit 3

Exclusion Criteria:

* Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg
* Secondary form of hypertension
* Current diagnosis of heart failure (NYHA Class II-IV)
* Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates)
* Second or third degree heart block without a pacemaker
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply.
Blood, Muscle and Exercise Responses to Sodium Bicarbonate Supplementation

The aim of this study is to evaluate the changes in activity of transporters of H+ (monocarboxylate transporters; MCT1, MCT4, NHE) following sodium bicarbonate supplementation and subsequent exercise performance. Fifteen healthy men (age 18-35 years) will be invited to attend the laboratory on five separate visits to a randomized, double-blind, placebo-controlled study. Participants will be supplemented with a 0.3 g/kg dose of sodium bicarbonate or placebo (Analytical Pharmacy, Brazil) in opaque gelatin capsules. One hour after supplementation they will perform a 1-km time trial and every 10 minutes a blood sample will be collected. A muscle biopsy will be taken prior to supplementation, immediately prior to exercise, and immediately post-exercise. A questionnaire will be also used to evaluate the side-effects associated with sodium bicarbonate supplementation. Muscle and blood samples will be analysed for acidity and H+ and muscle samples will be analysed for H+ transporters (MCT1, MCT4, NHE).


Eligibility Criteria:
Inclusion Criteria:

* Healthy males

Exclusion Criteria:

* Smokers
* Chronic disease
* Prior or current use of steroids
* Use of creatine in the last 6 months
* Use of beta-alanine in the last 6 months
Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences

Psychological parameters among patients undergoing ACL reconstruction and their impact on the patient-reported and functional outcome of reconstruction will be prospectively evaluated


Eligibility Criteria:
Inclusion Criteria:

* ACL tear
* Over 18 years
* Patient information and consent
* No preexisting knee conditions prior ACL tear;

Exclusion Criteria:

* Under 18 years
* Preexisting knee conditions
* Accompanying knee injuries apart from ACL tear
Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery

This study aimed to verify whether an Opioid-free Anesthesia (OFA) could effectively reduce the incidence of PONV after thoracoscopic-assisted surgery compared with standard general anesthesia (OA) regimens.

Postoperative Nausea and Vomiting (PONV) is one of the most common complications after general anesthesia, which significantly reduces postoperative comfort and satisfaction of patients perioperatively. Meta-analysis showed that Opioid-free Anesthesia (OFA) significantly reduced the risk of postoperative PONV events in patients undergoing gynecology, breast, and abdominal surgery compared with standard general anesthesia (OA). The main hypothesis of the study is that an OFA could reduce the incidence of PONV in patients after thoracoscopic-assisted surgery than OA.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients planning elective thoracoscopic lobectomy or wedge resection under general anesthesia

Exclusion Criteria:

* ASA classification \> 4
* BMI\>35kg/m2
* Unable to communicate before surgery
* Received radiation therapy, chemotherapy, opioids or hormonal drugs within 14 days before surgery
* Anticipated intolerance to the anesthesia protocol of this study
* Expect prolonged mechanical ventilation after surgery
* Decline
Balance Training After Stroke - a Randomized, Controled Pilot Study

This pilot study is part of a master's thesis. In the rehabilitation of stroke patients should be compared whether individual balance training has a greater effect than group balance training. The result is determined based on the walking speed.

The RehaClinic Kilchberg is a neurological rehabilitation facility with the phases B-D. Between February and the end of March, out of 78 patients, 71% of the patients had a stroke. Therefore, my choice of topic for the Master's thesis fell on balance training of patients after a stroke. The duration of the study is based on the timetable for the Master's thesis. Initially, 20 stroke patients will be recruited. When the number is reached, the study is completed to begin descriptive statistics and analyze potential BIAS.

Deficits in the vestibular, visual, motor, and / or somatosensory systems lead to falls in the first 6 months after the stroke. This affects approximately 46% of patients. But also cognitive processes, such as attention and concentration. Therefore, the treatment must be adapted to the respective strategy of the patient. If the patient increasingly uses the visual system, the therapy has to work a lot with the eyes closed. In turn, if he uses more of the sensorimotor system is increasingly trained with unstable documents. After this system, the balance program was set up. It is the same for the intervention and control group to make a difference between individual and group training.

Eligibility Criteria:
Inclusion Criteria:

* stroke starting from Rehabilitation phase B
* ability to understand therapy instructions
* walkable with aids

Exclusion Criteria:

* Neurodegenerative disease
* non-stroke dizziness
* cardiopulmonary insufficiency
* polyneuropathy
* peripheral vascular disease
Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia

The purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin \<9 gr/dl , treated with venofer and women treated with ferinject.


Eligibility Criteria:
Inclusion Criteria:

pregnancy\>24 weeks of gestation anemia with Hb\<8 anemia with Hb\<9 if symptomatic anemia of previous postpartum hemorrhage

Exclusion Criteria:

* Allergy to one of the study's drugs
* IV iron treatment in the last month
* chronic anemia- thalassemia, renal failure Twins pregnancy
* non iron deficiency anemia
Effect of Lower Back Treatment in People With Patellofemoral Pain Syndrome.

The purpose of this study is to determine if a lower back treatment would change the knee pain intensity and the level of functional activities as well as the muscle activities in people with anterior knee pain. The investigators hypothesized that the lower back treatment may change the hip and knee muscle activities as well as reduce the knee pain intensity and improve the functional activities in people with anterior knee pain.


Eligibility Criteria:
Inclusion Criteria:

* Insidious onset of symptoms of non-traumatic origin.
* Pain with patellar facet palpation or compression.
* anterior or retropatellar knee pain during at least two of the following activities: (a) ascending stairs, (b) descending stairs, (c) kneeling, (d) squatting, (e) hopping, (f) running, (j) jumping, (h) prolonged sitting for more than 20 minutes.

Exclusion Criteria:

* History of spine, hip or knee surgery.
* History of hip pathology or other knee condition.
* Current significant injury of any lower extremity joints.
* Pregnancy.
* Sign of nerve root compression.
* Osteoporosis or history of compression fracture.
Appetite Hormones in Binge Eating Disorder

This study investigates the hormones that the body produces in response to food intake and in response to stress, and the way that stress influences food intake. In particular, it compares the hormone levels and food intake of people with and without binge eating disorder. In order to find out how these appetite- and stress-related hormones are linked to brain activity, the study also includes an fMRI scan, a non-invasive procedure that looks at which regions of the brain are most active during a food-related scenario.

The objectives are to study appetite-related hormones regulating food intake under normal conditions and following a stressor in the morning and evening (when most binge episodes occur), to help reveal biological mechanisms in BED. We plan to enroll: 32 obese Ss with BED (16m, 16f), 32 obese Ss without BED (16m, 16f) and 32 normal-weight Ss without BED (16m, 16f). Height, weight, waist circumference, and body fat will be assessed during a first appointment. On two different days separated by at least a week, Ss will ingest a fixed liquid meal once in the morning and once in the evening. Appetite ratings and collections of blood and saliva to measure hormones will continue for 2 hours after the fixed meal. This will be followed on each day by a laboratory stress protocol (Socially Evaluated Cold Pressor Test; SECPT), and then consumption of an ad libitum meal 30 minutes later. On one day during the protocol, the participant will collect saliva using a swab immediately after waking and again at 08.00. In order to capture more naturalistic eating episodes, all Ss will additionally record food intake, rate appetite, and measure salivary cortisol before and after one evening meal, and one after-dinner snack (or after-dinner binge for BED Ss). On two additional days, we will use fMRI to assess brain activation in response to high-palatability food (HPF) relative to low-palatability food (LPF) or non-food (NF) visual cues following the SECPT and a control condition using warm water. On each day, following the fMRI scan, an ad libitum meal will be consumed.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 20-25 or 30-50
* stable weight(± 4%) for at least 3 mo
* premenopausal and have regular menstrual cycles (28 d ± 5), not be pregnant or lactating, and not be within 1 y of childbirth
* must like pizza and be willing to consume it during the ad libitum meal

Exclusion Criteria:

* significant medical or psychiatric conditions
* current and past 3-mo use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (\> 3 drinks/d)
* vigorously exercise for more than 6 h/wk
* left-handed, with known claustrophobia for a scanner enclosure, or have metal implants, non-removable metallic dental retainers, pacemakers, or permanent eyeliner or large tattoos that contain metallic pigment
Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use this information to develop new treatments for heart failure.


Eligibility Criteria:
Inclusion Criteria:

* HFpEF criteria

  1. Age ≥30 years.
  2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
  3. Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following:

     1. Elevated BNP (≥75 pg/ml in sinus rhythm or ≥225 pg/ml in atrial fibrillation/flutter) or NTproBNP (≥225 pg/ml in sinus rhythm or ≥675 in atrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center.
     2. Prior HF hospitalization (primary reason for the hospitalization is HF with elevated natriuretic peptide levels \[using the thresholds listed above\], requiring IV diuresis for HF, or pulmonary edema or pulmonary vascular congestion on chest radiography).
     3. Previously documented elevated pulmonary capillary wedge pressure (PCWP) at rest (≥15 mmHg) or during exercise (≥25 mmHg for supine exercise or PCWP/cardiac output ratio ≥2 mmHg/L/min for upright exercise).
     4. Elevated H2FPEF score69 (≥5) or HFA-PEFF70 score (≥5).

Suspected HFpEF criteria

1. Age ≥30 years.
2. Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
3. Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following:

   1. Does not meet BNP or NT-proBNP criteria for HFpEF (above)
   2. No prior HF hospitalization meeting HF criteria (above)
   3. No previous hemodynamic catheterization documentation of HF (as above)

Exclusion Criteria:

* 1. Inadequate echo or fluoroscopic images.

  2. Neck anatomy unfavorable for jugular venous cannulation

  3. Therapy with direct oral anticoagulants without cessation for a period (age, renal function, and agent specific) deemed adequate to normalize coagulation according to local clinical guidelines.

  4. Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before or of EMB

  5. Platelet count \< 50,000/ml

  6. Active bleeding or coagulation disorder

  7. Infection or fever

  8. Endocarditis

  9. Pregnancy

  10. Intracardiac thrombus

  11. RV Aneurysm

  12. Clinically significant tricuspid, pulmonary or aortic valve stenosis

  13. Tricuspid or pulmonary mechanical valve prosthesis

  14. Left bundle branch block
Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects

This is a phase I, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of ASC10 tablets and an open-label, crossover design to evaluate the food effect on PK of ASC10 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers between the ages 18 and 45, inclusive
* Those who do not have plans for pregnancy within six months and are willing to take effective contraceptive measures from the first dose of the study drug to 3 months after the last dose.
* If male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug.
* Body mass index (BMI) was between 19 and 26 kg/m\^2. Weight ≥50 kg for males and ≥45 kg for females.

Exclusion Criteria:

* Females who are pregnant, planning to become pregnant, or breastfeeding.
* Has any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
* Has a history of cancer (other than basal cell or squamous cell cancer of the skin), rheumatologic disease or blood dyscrasias.
* Has a history of blood dizziness or difficulty in blood collection.
* Has donated blood within 30 days, plasma within 2 weeks, or platelets within 6 weeks before the first dose of study drug.
Effect of Deferasirox on Patients With Cardiac MRI T2* < 20 Msec

This study will assess the safety and efficacy of deferasirox in patients with cardiac MRI T2\* \< 20 msec.


Eligibility Criteria:
Inclusion Criteria:

* β-thalassemic patients receiving regular transfusions with an history of at least 20 transfusional events
* Patients naïve for deferasirox
* Serum ferritin levels ≥1000ng/ml (average of the last 6 months assays);
* Cardiac MRI T2\* \>5 and \<20 msec.
* LVEF at MRI ≥56%

Exclusion Criteria:

* Patients that have already started deferasirox therapy
* Existing contraindications to the performance of MRI procedure, including presence of metallic prostheses not compatible with the MRI procedure other than those approved as safe for use in MRI scanners (e.g., some types of aneurysm clips, shrapnel in proximity to vital organs such as the retina), pacemaker, intractable claustrophobia and incapability to follow the instruction for the correct performance of the MRI (e.g. to maintain a supine position, to hold breath, etc.)
* Clinical conditions requiring intensive chelating therapy on the basis of Investigator's judgment
* Stable average ALT levels \>300 U/L in the preceding 12 months
* Uncontrolled systemic hypertension
* Estimated creatinine clearance \<60 ml/min
* History of nephrotic syndrome
* History of clinically significant ocular toxicity related to the chelating therapy
* Psychiatric disorders or drug dependence that might impair the capability of the patient to provide their Informed Consent or to be administered the study treatment
* Known sensitivity to study drug(s) or class of study drug(s)
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Use of any other investigational agent in the last 30 days.

Other protocol-defined inclusion/exclusion criteria may apply.