cyrilzakka/clinical-trials huggingface dataset:
OPC-61815 in Healthy Chinese Male Subjects

To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of OPC-61815 in healthy Chinese Male subjects

To evaluate the pharmacokinetic (PK) characteristics of single and multiple intravenous administration of OPC-61815 in healthy Chinese subjects.

To evaluate the safety of single and multiple intravenous administration of OPC-61815 in healthy Chinese subjects.

To evaluate the pharmacological effect of single and multiple intravenous administration of OPC-61815 in healthy Chinese subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 18-45 years (including the cutoff values, subject to the time of signing the Informed Consent Form (ICF));
* Body mass index (BMI) of 19-26 kg/m2 (including the cutoff values), with a body weight of not less than 50 kg for male subjects;

Exclusion Criteria:

* Those whose the sitting pulse is lower than 50 beats/min or higher than 100 beats/min after resting for over 3 minutes.
* Those whose sitting SBP is lower than 90 mmHg or higher than 140 mmHg, or DBP is lower than 50 mmHg or higher than 90 mmHg after resting for over 3 minutes.
* Various micturition disorders (pollakiuria or dysuria, etc.).
Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma

Primary Aim Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma (cancer of the liver that can't be treated surgically).

Secondary Aims

1. Determine the toxicity of this combination in this population.
2. Determine the survival of this patient cohort treated with the combination.
3. Determine the percent of patients with hepatocellular carcinoma who have a positive octreotide scan.

The purpose of this study is to determine the response rate and time to progression of the combination of thalidomide, alfa interferon, and octreotide (Sandostatin LAR) in patients with unresectable hepatocellular carcinoma. If patients are eligible for and agree to take part in the study, they will be assigned to one of two treatment arms depending on SSR status. If SSR status is positive or unknown, patients will receive oral doses of thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week depending on tolerance. They will also receive injections three times a week of alpha interferon and monthly injections of octreotide (Sandostatin LAR) 30 mg into their buttocks muscle..

If the patient SSR status is negative, patients will not be given subcutaneous injections of octreotide (Sandostatin LAR) but will receive the thalidomide and alfa interferon only.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein \>500 ng/ ml
2. The tumor is unresectable
3. Performance status of \< 2.0
4. \> 18 years of age
5. Informed consent to be signed by patient
6. No previous treatment with thalidomide, alpha interferon, or octreotide
7. The patient may have received previous chemotherapy either systemically or via the intra hepatic artery.
8. The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation.
9. The patient must have measurable disease.
10. If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy.
11. Bilirubin \<3 X ULN, AST/ALT\<3 X ULN, creat\<2, ANC\>1.5, Platelet\>75K
12. Patients may not have symptomatic cholelithiasis.

Exclusion Criteria:
Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease

The central hypothesis of this proposal is that a reduction in hepatic mitochondrial function is the main pathophysiology behind NAFLD (Non-Alcoholic Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content and function in human subjects.

The investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH

Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content and function in human subjects.

The investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH

Eligibility Criteria:
Inclusion Criteria:

* sedentary individual between
* age group 18-60 years old
* elevated Liver Function Tests (LFT's) with fatty liver on ultrasound and biopsy proven NASH

Exclusion Criteria:

* significant history of alcohol consumption \> 20 gm/day (\> 2 drinks / day)
* evidence of other causes of hepatitis including positive screening B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha 1 antitrypsin deficiency or medication-induced hepatitis
* Subjects with planned exercise \> 30-60 minutes per week
* BMI \< 25 or \> 44 kg/m2
* clinical or biochemical evidence of decompensated liver disease, advanced cardiac or renal disease
* changes in last 3 months the dose of oral hypoglycemic medication and statin,
* positive stress test
* pregnant women
* demented individuals who cannot give consent
Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure

Assessing whether Preimplantation Genetic Testing for Aneuploidy (PGT-A) can increase the ongoing pregnancy rate per transferred embryo and can decrease the time to pregnancy and miscarriage rate in patients with Recurrent Implantation Failure (RIF)


Eligibility Criteria:
Inclusion Criteria:

* Women with recurrent implantation failure (previous transfer of least 4 good quality embryos in at least 3 fresh or frozen cycles)
* BMI \< 35
* Normal hysteroscopy

Exclusion Criteria:

* thin endometrium in previous cycles (\<6mm), endometriosis ASRM score III-IV, premature ovarian failure (POF, Bologna criteria), abnormal karyotype, donor oocytes or embryos, PGT-M
Efficacy of Extracorporeal Magnetic Stimulation, Pelvic Floor Muscle Exercise, and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence

Urinary incontinence is one of the most common complications of radical prostatectomy. Multiple prevention and treatment modalities have been proposed in the management of post prostatectomy urinary incontinence. This is a randomized controlled comparative study to evaluate the efficacy of extracorporeal magnetic stimulation alone and combined with pelvic floor muscle exercise versus pelvic floor muscle exercise alone in the management of post radical prostatectomy urinary incontinence. This study is expected to be performed over 7 years. The study population will be all male patients who are prepared for radical prostatectomy under urology department in HMC and were referred to voiding dysfunction for preoperative counselling and postoperative rehabilitation. Patients will be randomized into one of three treatment groups. The first group will receive sessions of extracorporeal magnetic field stimulation only. The second group will receive extracorporeal magnetic stimulation in addition to pelvic floor muscle exercise. The third group will receive pelvic floor muscle exercise only. The recruitment phase will take 3 years. Patients will be followed for 18 months for the course of urinary incontinence symptoms, severity of urinary incontinence on 1-hour pad test, urodynamic leak point pressure and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and the ICIQ quality of life (QOL) score. This study is proposed to reveal strong evidence on the efficacy of extracorporeal magnetic stimulation on the management of post radical prostatectomy urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* The study population will include all adult male patients 18 years of age and above, with localized prostate cancer of low or intermediate risk disease who chose definitive treatment with radical prostatectomy either through open radical retropubic prostatectomy (RRP) or through robotic assissted laparoscopic radical prostatectomy (RALP) as first line for treatment and had the surgery under Hamad General Hospital urology department care.

Exclusion Criteria:

* Patients with high risk , locally advanced or metastatic prostate cancer at time of diagnosis
* Patients with low to intermediate risk prostate cancer who received chemo or radiotherapy then had salvage surgery
* Patients with urinary incontinence or diagnosed overactive bladder before radical prostatectomy.
* Patients with complicated surgery resulting in anastomotic leak, prolonged catheterisation more than 3 weeks, reinsertion of catheter due to retention of urine.
* Patients who refuse to participate in the clinical trial.
Cobalamin Status in Young Children With Developmental Delay

During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. During the last years we have detected cobalamin deficiency in a number of infants admitted to the Pediatric Department with various symptoms, including neurological symptoms and feeding problems. Cobalamin treatment is given to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved physical condition.

In this study we want to establish the prevalence of cobalamin deficiency in infants with developmental delay and regression and other vague neurological symptoms. Cobalamin status will be investigated in all children aged 8 months and younger, admitted to the Pediatric Department with these symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin supplementation in children with these symptoms and metabolic evidence of impaired cobalamin status.

Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin deficiency, will lead to loss of symptoms and in improved physical condition.


Eligibility Criteria:
Inclusion Criteria:

* Children below 8 months of age
* Clinical diagnosis or symptoms: developmental delay and regression and other vague neurological symptoms

Exclusion Criteria:

* Children with syndromic disease
Erythema at Exit Site & Tablet Camera

Background: In critical care medicine central venous catheters play an important role in the source of infections. In the daily routine prior to the diagnosis the suspicion of catheter related infection is discussed in the medical team due to signs of systemic inflammation or exit site infection like erythema, induration or tenderness. However, if an erythema at exit site of a central line can be quantified with a tablet camera, is unknown.

Methods: Standardized set of photos will be taken of 10 central lines with a reddened exit site and 10 catheters without an erythema (as a control over time) with a tablet camera and a single-lens reflex camera. The percentage of usable images between tablet and single-lens reflex camera will be analysed. Furthermore, two independent clinical experts from dermatology will grade blinded de-identied images on a scale from 0 to 4 (0 - no erythema, 1- very faint, 2 - faint, 3 - bright, 4 - very bright).

Objectives: The primary objective of this feasibility study aims to analyze the reliability of a tablet camera as a device for quantification of erythema around an exit site.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Jugular CVC or Subclavian CVC
* ICU-Admission

Exclusion Criteria:

* \< 18 years
* Pregnancy/Lactation
* HIV
* neutropenia (\<1000/m3)
* hematologic tumor
* dark pigmentation
* prone position within the last 24 hours
* head/neck-area: cancer, operation, burns or radiation, tattoos
Comparison of Xtreme CT and DXA Bone Densitometry

Dual-energy x-ray absorptiometry (DXA) is currently the most widely used tool for determining bone density. However, most experts consider DXA an imperfect and intermediate technology. DXA is subject to artifact from arthritis and body composition, and also cannot account for geometric or material properties of bone which are also important components of bone strength.

Xtreme CT (high-resolution peripheral quantitative computed tomography, HR-pQCT) is a new technology with dramatically improved spatial resolution. It is able to define bones' cortical and trabecular surfaces in a three-dimensional manner, and therefore provides information on bone microarchitecture as well as bone density. As such, it may provide new information about characteristics of bone strength.

The purpose of this study is to compare Xtreme CT to DXA measurements of bone density, and also to generate a normative database of healthy young adults. This cross-sectional study involves a single visit where both Xtreme CT and DXA measurements will be obtained for a single time-point. This normative database will allow us to generate clinically relevant comparisons between the two imaging technologies.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 20-40 years

Exclusion Criteria:

* Pregnancy
* History of bone modifying diseases (hyperparathyroidism, Paget's, hyperthyroidism, renal failure, nephrolithiasis, liver disease, eating disorder)
* History of amenorrhea
* Use of chronic steroids for \>3 months
Comparison of Positive Psychotherapy and Cognitive-Behavioral Psychotherapy for Depression

This study evaluates the effects of the Positive Psychotherapy on depressive symptoms and on happiness compared with regular cognitive behavioral therapy.

Positive Psychotherapy (PPT) focuses on increasing well-being and positive emotions rather than ameliorating deficits in contrast to standard psychotherapy.

A lack of positive emotions, engagement and felt meaning are typically viewed as consequences or mere correlates of depression, while the PPT suggests that these may be causal for depression. Therefore building positive emotion, engagement and meaning will alleviate depression.

Thus PPT may offer a new way to treat and prevent depression.

The aim of this study is to compare the effects of the Positive Psychotherapy on depressive symptoms, life satisfaction and happiness in comparison to standard cognitive behavior psychotherapy (regular cognitive behavioral therapy).

60 mildly to moderately depressed patients are randomly assigned to the Positive Psychotherapy group or the regular cognitive behavioral therapy group.

Both treatments (primary intervention group and control group) are conducted in an outpatient group therapy setting with 14 sessions and a duration of 2-hours-per-week in small groups of 6 or 7 patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Depression (Major depressive disorder, recurrent: mild to moderate; Major depressive disorder, single episode: mild to moderate; Dysthymic disorder)
* Patients should be between age 18 and 60

Exclusion Criteria:

* Any current treatment for depression
* Substance related or alcohol related disorder (within the last 12 months)
* Panic disorder
* Manic or hypomanic disorder
* Psychotic disorder \* refusal to participate in a 14 weeks psychotherapy treatment
Primary Hyperparathyroidism: Non-classical Manifestations

This is a research study to investigate cardiovascular health in people with mild hyperparathyroidism. Previous research has suggested that severe hyperparathyroidism may be associated with abnormalities in the heart and blood vessels. It is unclear whether mild hyperparathyroidism affects cardiovascular health. This study involves the investigation of the heart and blood vessels of people with mild hyperparathyroidism. Various non-invasive laboratory and radiological test to assess cardiovascular and bone health will be done at set intervals over the course of 2 years. It is our hypothesis that patients with primary hyperparathyroidism will have subtle abnormalities in their cardiovascular system. Using state-of-the art techniques that are sufficiently sensitive to detect these subtle abnormalities, we will define cardiovascular features of this disease that have, up to now, eluded clear definition. We expect taht the extent of these findings will be related to the severity of the underlying primary hyperparathyroidism. We further hypothesize that cardiovascular manifestations may regress with successful cure of the hyperparathyroid state.

This study involves a total of 4 visits over a 2-year period. A variety of tests to evaluate your cardiovascular and bone health are performed. The details and timing of the tests are explained below.

VISIT #1 During the first visit, a research doctor or assistant explains the procedures in detail and answers questions. Blood is drawn (about 1-2 tablespoons) to confirm the diagnosis of hyperparathyroidism and get baseline blood values.

VISIT #2-4 During the following visits, a variety of procedures are performed to evaluate cardiovascular and bone health. The details of the procedures and when they will be performed are outlined below.

1. Blood tests are performed at each visit. Approximately 1-2 tablespoons of blood will be drawn at each visit.
2. A 24-hour urine collection is done 3 times during the 2 year study.
3. Bone mineral density testing (known as DXA) is performed at baseline, 12 and 24 months after enrollment.
4. Carotid Ultrasound: At the baseline visit, 12 and 24 months after enrollment, carotid ultrasound is performed.
5. Echocardiogram: At the baseline visit, 12 and 24 months after enrollment, an echocardiogram is performed.
6. Endothelial Function: At baseline, 6 and 12 months after enrollment, flow mediated dilation of the brachial artery is performed.

Eligibility Criteria:
Inclusion Criteria:

-Primary Hyperparathyroidism

Exclusion Criteria:

* Current use of oral bisphosphonates
* Addition or change in cholesterol lowering medication
* impaired renal function (creatinine \>2.0 mg/dl)
Pain Relief From Dysmenorrhea Employing taVNS

The goal of this clinical trial is to determine if transauricular vagal nerve stimulation (taVNS) is effective in treating moderate dysmenorrhea. The main question it aims to answer is:

• Does taVNS reduce the number of times participants suffering from dysmenorrhea need to use rescue medication during menstruation? Researchers will compare taVNS stimulation with a sham stimulation (a look-alike procedure that does not stimulate the vagus nerve) to assess whether taVNS is effective in treating moderate dysmenorrhea.

Participants will:

* Undergo taVNS for 2 months and sham stimulation for another 2 months, each for 5 days per month, starting 2 days before the expected beginning of their menstrual cycle.
* Visit the clinic twice a month for checkups and tests.
* Keep a diary to record their pain levels and the number of times they use rescue medication.
* Undergo functional magnetic resonance imagine two times (one after the end of the first use of taVNS and another after the end of the first use of SHAM stimulation).


Eligibility Criteria:
Inclusion Criteria:

* Regular menstrual cycle (28 days ± 7 days);
* Average moderate menstrual pain (with 4 - 7 NRS scores);
* History of over-the-counter (OTC) analgesic use for the treatment of menstrual pain (at least 1 IBUPROFEN for the first two days);
* 4 consecutive monthly menstrual cycles;
* Non-pregnant status;
* Agrees to use adequate birth control during the trial;
* Otherwise, healthy;
* Agree not to participate in any other clinical trial while enrolled in this trial ;
* No facial or ear pain, no recent ear trauma, no metal implants including pacemakers;
* Normal ECG, Heart Rate and Blood Pressure (systolic BP 105-130, diastolic BP 60-90, heart rate per min at rest 60-85);

Exclusion Criteria:

* Currently under medications (except for analgesic medication for menstrual cycle);
* Use of oral contraceptive;
* Secondary cause for dysmenorrhea (i.e., endometriosis, adenomyosis, uterine fibroids, or infection);
* Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed psychological or mood disorder, hypertension, any bleeding disorders, recent surgery, or concurrent blood thinning treatment);
* Current malignancy or treatment for malignancy within the previous 2 years;
* Pregnant or lactating women;
* Active smokers, nicotine use, or drug (prescription or illegal substances) abuse;
* Chronic past and/or current alcohol use (\>14 alcoholic drinks per week);
* Any condition that in the opinion of the investigator, makes the participant unsuitable for inclusion;
* Unwilling or unable to comply with protocol;
* Active genitourinary infection in the last four weeks;
* Unable to read or comprehend the informed consent;
* Unwilling to complete study procedures;
* Participated in any other clinical trial during the past 1 month;
* Personal or family history of seizure, mood, or cardiovascular disorders;
* Allergic reaction to surface electrodes.
Bedside Genetic or Pharmacodynamic Testing to Prevent Periprocedural Myonecrosis During PCI (ONSIDE TEST)

Patients undergoing percutaneous coronary intervention with a residual high platelet reactivity despite oral clopidogrel are at increased risk of ischaemic complications. The strategies to overcome the issue consist of switch to a more potent antiplatelet medications including prasugrel or ticagrelor. Economic constrains of many countries still do not allow wide reimbursement of newer antiplatelet agents. Therefore a strategy to personalise treatment according to genotype and phenotype characteristics of the patient may provide an attractive solution combining high clinical efficacy with low budget impact.


Eligibility Criteria:
Inclusion Criteria:

* age 18-75
* elective PCI

Exclusion Criteria:

* acute coronary syndrome (troponin \> 1 x ULN),
* administration of glycoprotein IIb/IIIa inhibitors,
* chronic total occlusion,
* lesions with extensive calcifications requiring rotational atherectomy,
* platelet count \<70 000 /µl
* high bleeding risk,
* coronary bypass surgery in the previous 3 months,
* severe chronic renal failure (eGFR \< 30 mL/min)
* requirement for warfarin, dabigatran, apixaban, rivaroxaban
* history of stroke or TIA,
* weight \< 60 kg
* known bleeding diathesis,
* hematocrit of \< 30% or \>52%
* pregnancy
Determinants of Compliance With Glaucoma Therapy

To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device.

To determine the association between medical, demographic, socioeconomic, and therapeutic differences on compliance with topical glaucoma therapy using the Travalert device. All participants will have open angle glaucoma.

Eligibility Criteria:
To be eligible to participate in the study, patients had to be (1) 19 years or older; (2) have a diagnosis of open angle glaucoma (OAG) in 1 or both eyes or ocular hypertension; and (3) using a prostaglandin ocular hypotensive medication in 1 or both eyes.

The protocol excluded patients with uncontrolled IOP control, known contraindications to Travoprost, clinically significant systemic disease that would interfere with the study, participation in any other research study within 30 days, or change in systemic medications that may alter IOP within 30 days before recruitment.