cyrilzakka/clinical-trials huggingface dataset:
Dose-finding Study for Vitamin K2 in Human Volunteers

Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins, Menaquinone-7 (MK7) has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains which dosage of MK7 leads to optimal carboxylation levels of these proteins.

The primary objective of this double-blind randomized intervention study is to establish the optimal dose of MK7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at which osteocalcin and matrix-gla protein are \> 90% in the active (=carboxylated) form.

This study is a double-blind randomized intervention study. In total 42 healthy volunteers (men and women) between 18 and 45 years will be recruited among the Maastricht University community (coworkers/students) and randomized into one of the following groups:

Placebo, 10 mcg MK7, 20 mcg MK7, 45 mcg MK7, 90 mcg MK7, 180 mcg MK7, 360 mcg MK7.

Each group will consist of 6 volunteers with approximately equal numbers of men and women (3 men / 3 women). A double-blind design of the study is chosen to avoid the occurrence of bias during the study. The randomization procedure will be performed by an investigator who is not involved in the coordination of the study and will generate specific randomization codes for each subject. After randomization, the volunteers consume the indicated amount of capsules once daily with either breakfast of dinner during a period of 12 weeks.

During the first week, blood samples of the volunteers will be collected at day 0, 1, 3 and 7 to study immediate effects on carboxylation of OC and MGP. After the first week, blood samples will be drawn every first day of week 2, 4, 6, 8, 10, and 12.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults between 18 and 45 years of age.
* Subjects of normal body weight and height according to BMI \< 30
* Subject has given written consent to take part in the study

Exclusion Criteria:

* Subjects with (a history of) metabolic or gastrointestinal disease
* Subject with (a history of) soy allergy
* Subjects using vitamin supplements containing vitamin K
* Subjects presenting chronic inflammatory diseases
* Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
* Subjects receiving corticoϊd treatment
* Subjects using oral anticoagulants
Efficacy and Safety of Paclitaxel-eluting Balloons for Below the Knee Peripheral Arterial Disease

Comparing the efficacy and safety of drug-eluting balloons (DEB) for the treatment of below-the-knee peripheral arterial occlusive disease with conventional balloon angioplasty (BA).

Over the past decade, percutaneous transluminal angioplasty (PTA) has established its position in the treatment of below the knee arterial occlusive disease with intermittent claudication and/or critical limb ischemia. However, the efficacy of percutaneous transluminal angioplasty (PTA) with conventional balloons, is limited by the high 12-month restenosis and target lesion revascularization (TLR) rates. Local delivery of newer anti-proliferative drug via drug-eluting balloons (DEBs) has recently shown promising results in the treatment of femoropopliteal disease, and in the BTK area, a reduction in 3-month binary restenosis has been observed compared with historical controls treated with PTA. Drug eluting balloon has three potential advantages: (1) homogenous drug transfer to the vessel wall; (2) highest drug concentrations at the vessel wall at the time of injury; and (3) absence of a stent or delivery polymer.

This study sought to investigate the long-term efficacy and safety of new drug (Paclitaxel)-eluting balloons (DEB) for the treatment of below the knee peripheral arterial disease.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Peripheral vascular disease with or without diabetes.
2. Rutherford class 2-6.
3. Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.
4. Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.
5. Written informed consent signed by the patients or representatives

Exclusion Criteria:

1. Previous bypass surgery or stent placement at the ipsilateral lower limb
2. History of intolerance to antiplatelet therapy, heparin, or contrast media.
3. Bleeding diathesis;
4. Active systemic bacterial infection;
5. Severely impaired renal function (serum creatinine level \> 2.5 mg/dL.
6. Expected survival time of less than 24 months
United for Health: Type 2 Diabetes Prevention in Latino Teens

This study pilots the feasibility and acceptability of a family-based lifestyle intervention for decreasing diabetes risk called "Salud sin Barreras" (meaning, "Health without Barriers") delivered in the community to Latino teens at risk for type 2 diabetes. This program combines traditional lifestyle intervention to change eating and physical activity with learning mindfulness-based stress reduction tools. We also are exploring how Salud sin Barreras lowers stress and improves insulin resistance in Latino teens, as compared to lifestyle-only intervention, the "La Vida Saludable" (meaning, the Healthy Living Program; HeLP).

This study is a comparative effectiveness pilot trial to evaluate the feasibility and acceptability of a 12-session community-delivered, family-based type 2 diabetes preventative lifestyle intervention, delivered over 6 weeks, that includes mindfulness-based stress reduction training - "Salud sin Barreras" (meaning, "Health without Barriers") - in up to 50 Hispanic/Latino adolescents who are at-risk for developing type 2 diabetes. We also will estimate the effectiveness of Salud sin Barreras for lowering perceived stress and improving insulin resistance as compared to a time-matched lifestyle-only intervention, the "La Vida Saludable" (meaning, the Healthy Living Program; HeLP) in Hispanic/Latino adolescents at-risk for type 2 diabetes. In addition, we will estimate the impact of the Salud sin Barreras program, relative to HeLP, on the secondary outcomes of mindfulness, depressive symptoms, disinhibited eating behavior, sleep quality, physical activity, cortisol, and perceived impact of discrimination.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-15 years
* Identify as Hispanic/Latino
* English speaking
* At-risk for T2D by virtue of current BMI ≥ 85th percentile for age and sex by CDC 2000 standards and ≥ 1 first or second degree biological relative with T2D, prediabetes, or gestational diabetes
* Currently a Salud Family Health Center patient or willing to become a patient of Salud Family Health Center (required to complete medical assessments at Salud)

Exclusion Criteria:

* Major medical problem, including type 1 diabetes or T2D
* Reported psychiatric disorder that would impede compliance in the opinion of the investigators
* Started use of medication affecting mood or body weight, such as stimulants or anti-depressants within the past 3 months
* Any medical issues that could be acutely worsened by exercise such as severe or uncontrolled asthma or musculoskeletal problems
* Self-reported pregnancy in girls
Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty

This study will compare the analgesic efficacy of daily single-shot adductor canal block(ABC) versus continuous ACB after total knee arthroplasty (TKA).

Patients 19-75 years old, of ASA classification I-III scheduled for unilateral TKA, will be enrolled and randomized into two groups, single-shot ACB group and continuous ACB group. In both groups, participants will be administered a single-shot ACB immediately after the end of the operation. The single-shot ACB group will receive two separate single-shot ACBs, on the first and second postoperative day. A nerve block catheter will be placed in patients in the continuous ACB group, which will be connected to a patient-controlled analgesia pump until the second postoperative day. The primary outcome of this study is the average NRS pain score at rest from the end of surgery to 2 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification I, II, III
* Patients scheduled for unilateral knee arthroplasty

Exclusion Criteria:

* Anesthesia other than spinal anesthesia
* Chronic opioid use
* Uncontrolled diabetes of HbA1c\>7.5
* Neuromuscular pathology of the ipsilateral leg
* Second-look knee arthroplasty
* Inability to communicate (e.g. dementia)
* Hypersensitivity to ropivacaine
* BMI \> 40
* Pregnancy
Relations Between Myotonia and Fitness

Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia.

Investigators aimed to investigate whether a 10-week bicycle exercise program can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia in everyday life. The effect on myotonia is assessed by a standardized myotonia scale with six statements concerning self-rated myotonia, and a number of performance tests that objectively describes the degree of myotonia.

The effect of the training program is assessed by an incremental test, measuring maximal oxygen uptake, maximal heart rate and maximal workload. The muscle enzyme creatine kinase (CK) is measured in plasma to follow muscle injury and safety during the training.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with either Myotonia congenita or Paramyotonia congenita.
* Patients who have symptoms of myotonia while they are walking stairs.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Physical or mental condition, which prevent participating in the study protocol or which could influence the results.
* Participating in other studies, which could influence the results.
Arabic Version QOL Questionnaire Chronic Wound

The aim of this study is to Help clinician modification of treatment through assess the validity and reliability of Arabic version of 17 items QOL questionnaire in patients with chronic wound. It translated to many languages but not present in form of arabic version.

The study will be cross sectional.participants: 100 patients according to sample size calculations suffering from chronic wound with age between 40-60 years. Using the minimum acceptable ICC of 0.75, expected ICC of 0.85, significance level 0.05, statistical power 80% and number of repetitions 2, the required sample size is about 100 subjects.The patients who met the inclusion criteria will be recruited. The purpose, significance, and procedures of the study will be explained to them, and written informed consent Will be obtained before enrollment.The researcher will measure the wounds and collect disease-related data during dressing changes. The participants will then be asked to fill out the questionnaires by themselves or with the help of the researcher.Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much). On obtaining at least 75% response, the researcher calculated a second-order global score as well as scores for every dimension as the mean of the respective responses. Higher scores indicated greater impairment of the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients who suffering from chronic wound at least 1 month prior to study enrollment,
* Patients aged between 40-60 years .Provision of written informed consent. .All participants will be able to read and write in Arabic language. .All participants can understand items of the questionnaire.

Exclusion Criteria:

* Patients who had mental illnesses
* Patients who were unable to fill in the questionnaire independently or answered the questions orally .Patient with communication, vision, hearing disorders. .Patient who doesn't fill the questionnaire till the end.
* Patient who were isolated due to infection
Fixed-dose Activated Versus Variable-dose Inactivated Prothrombin Complex Concentrate for Warfarin-associated Major Bleed

This study aims to assess a fixed-dose regimen of activated prothrombin complex concentrate (FEIBA VH, Baxter) versus the variable, manufacturer recommended, dose regimen of inactivated prothrombin complex concentrate (Kcentra, CSL Behring) for reversal of warfarin-associated major hemorrhage.

Warfarin, a vitamin K antagonist (VKA), is the most frequently prescribed oral anticoagulant. Warfarin-associated major hemorrhage occurs at a rate of 1.7% to 3.4% in routine clinical practice and warrants rapid reversal of anticoagulation by correcting supratherapeutic international normalized ratio (INR) values.

Warfarin inhibits synthesis of vitamin K dependent coagulation factors II, VII, IX, and X, and strategies for reversal of warfarin-associated coagulopathy are aimed at restoring deficient factors. Four-factor prothrombin complex concentrates (PCCs) contain the coagulation factors which warfarin inhibits and are an attractive option for rapid reversal due to ease of reconstitution and no requirement for blood-type matching.

Manufacturer dosing recommendations exist for PCCs based on patient weight, baseline INR, and target INR, but studies have suggested fixed dosing strategies in an effort to determine the most efficacious dose for VKA-reversal while sparing adverse events. These studies have also utilized different PCC formulations, with some studies utilizing 4-factor activated PCC (aPCC), which denotes product containment of factor VII in an activated state.

In the United States, product availability is limited to a single 4-factor aPCC (FEIBA VH, Baxter) indicated for hemophilia patients with inhibitors and a single 4-factor inactivated PCC (Kcentra, CSL Behring) approved for VKA-reversal. Various institutions choose to utilize off-label fixed dosing strategies of 4-factor aPCC in an effort to administer the lowest possible dose to reverse VKAs, while others utilize manufacturer recommended dosing of 4-factor inactivated PCC.

Eligibility Criteria:
Inclusion Criteria:

* Pre-treatment INR lab value greater than 1.5
* Receipt of treatment with a 4-factor PCC for INR normalization due to warfarin-associated major hemorrhage

Exclusion Criteria:

* Patients treated with a PCC for an urgent invasive procedure without active hemorrhage
* Patients treated with PCC not taking a VKA
* Unavailable pre- or post-treatment INR lab values
* Pregnant patients
Automated ICD Coding of Primary Diagnosis Based on Machine Learning

This study aims to develop and validate machine learning model in ICD-10 coding of primary diagnosis related to cardiovascular diseases in Chinese corpus.

The accuracy and productivity of ICD coding has always been a concern of clinical practice. Errors of ICD codes may result in claim denials and missed revenue. However, ICD coding process is complex, time-consuming and error-prone. More experienced coders are in need, but there is an increasing lack of supply. Automated ICD coding has potential to facilitate clinical coders for improved efficiency and quality. Model performance of related studies is still far below coders and both the accuracy and interpretability need to be improved in great demand. Besides, studies in Chinese corpus are not sufficient.

In this study, the investigators will implement automated ICD coding study based on inpatient' data collected from electronic medical records from Fuwai Hospital, the world's largest medical center for cardiovascular disease. Feature engineering and machine learning methods will be used to develop classification models with good performance, interpretability and practicability for ICD codes of primary diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Admissions in Fuwai Hospital, from January 1, 2019, to December 31, 2020

Exclusion Criteria:

* Admissions stayed in nephrology department, Fuwai Hospital
Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa

Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor 1 (IGF-1), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels of growth hormone. It is possible that deficiency of insulin-like growth factor 1, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in anorexia nervosa. The physiologic effects of recombinant human insulin-like growth factor 1 (rhIGF-1) treatment in adolescents and young adults with anorexia nervosa have not been studied. The goal of this proposal is to investigate the effects of recombinant human insulin-like growth factor 1 on bone density and bone microarchitecture in adolescent girls and young adult women with anorexia nervosa over a 6 month period. We hypothesize that adolescent and young adult anorexia nervosa patients, being insulin-like growth factor 1 deficient, will respond to exogenously administered recombinant human insulin-like growth factor 1 with elevations in biochemical indices of bone turnover and an increase in bone density and improvement in bone structure, or maintain bone density (in contrast to the decrease in bone density expected in adolescent girls and women with anorexia nervosa who are not treated).


Eligibility Criteria:
Inclusion Criteria:

- Meet criteria for anorexia nervosa (AN) as described in the Diagnostic and Statistical Manual of Mental Disorders

Exclusion Criteria:

* Pregnant or nursing
* Hematocrit \< 30%, K \< 3 mmol/L
* Any illness (other than AN) known to affect bone and mineral metabolism such as diabetes, untreated hypo- or hyperthyroidism, or hyperparathyroidism
* History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who are on estrogen will still be eligible to participate in the study because our data in adult women with AN do not indicate deleterious effects of estrogen in patients receiving rhIGF-
To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease

The purpose of this study is to evaluate whether treatment with single and multiple oral doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and Event-Related Potentials in patients with Alzheimers Disease. The total treatment period is 9 weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days each.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of probable Alzheimer´s Disease
* Hachinski Ischaemic score \< 4
* MSE score 18 to 24

Exclusion Criteria:

* History of any clinically significant disease or dementia other than Alzheimer´s Disease
* Current major depressive disorder or other major psychiatric disorders
Therapeutic Touch for Wrist Fractures in Postmenopausal Women

This study will evaluate the effectiveness of therapeutic touch in treating wrist fractures in women past menopause.

In the United States, the use of complementary and alternative medicine (CAM) increased by approximately 25% between 1990 and 1997. The number of visits to CAM practitioners exceeded visits to primary care physicians by about 250 million in 1997. Energy medicine modalities, including therapeutic touch, healing touch, and reiki, are commonly utilized for conditions ranging from headache to cancer, yet understanding of the human energy field and how it may be used in healing is limited. This study will examine the effect of therapeutic touch on fracture healing in postmenopausal women.

Women will be enrolled in the study within one week of a wrist fracture and will receive either therapeutic touch or a sham (placebo) treatment daily for 3 weeks. Assessments will include blood and urine analysis and measures of pain and function in the affected wrist.

Eligibility Criteria:
Inclusion Criertia:

* Postmenopausal
* Wrist fracture within 1 week of study entry
* Able to travel to research center for daily treatment
Various Techniques of Horizontal Ridge Augmentation

42 patients will be selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth or multiple teeth in posterior mandible by dental implant in horizontally atrophic ridge.


Eligibility Criteria:
Inclusion Criteria:

* Patient's cooperation, motivation and good oral hygiene.
* Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
* Moderately atrophic posterior mandibular alveolar ridge width (more than 4 mm), with minimum 10 mm height.
* Free from history of bruxism / parafunctional habits.

Exclusion Criteria:

* Patients with local pathological disease such as cyst, tumor at the planned surgical site.
* Pregnant patients.
* Heavy smoker patients.
Multiple Ascending Dose Tolerability, Pharmacokinetic and Pharmacodynamic Study of DG3173

This multi-ascending dose study is designed to investigate the safety, tolerability, pharmacokinetic and side effect profile of multiple ascending doses of DG3173, in up to 48 healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Ethnic origin: Caucasian
* Body Mass Index (BMI): 19-27 kg/m2 inclusive
* Medical history without clinically relevant pathologies
* Physical examination parameters without signs of clinically relevant pathologies
* Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) \<450 ms
* Values for hematology and for biochemistry tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator (in particular for alanine transaminase, aspartate transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, bilirubin, and α-amylase)
* Subjects with partner of child bearing potential must be willing to practice a medically approved method of contraception (e.g., condom in combination with hormonal contraception or intrauterine device or a diaphragm with spermicide after the first drug administration and for one month after participation in the study or are vasectomized since \> 6 months or has a partner being sterilized since \> 6 months
* Having given written informed consent before any study related activities are carried out

Exclusion Criteria:

* Evidence of clinically relevant pathology or disease
* Any history of moderate or severe hypertension, hypotension or orthostatic hypotension
* Mental handicap
* Legal incapacity
* Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy
* Chronic diarrhea or other acute or chronic gastrointestinal disorders
* Presence or history of endocrine disorders
* Presence or history of gallstone disease
* Known hypersensitivity to the study drug or constituent of the study drug
* History of any relevant allergy, especially drug and/or food allergies
* Strict vegetarian
* Regular treatment with medications during three months prior to randomization
* Receipt of any prescription or non-prescription medication, including multi vitamin preparations within 14 days prior randomization and for the duration of the study
* Use of St. John's Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours prior to randomization
* Participation in a clinical study within 30 days prior to randomization
* Donation of blood within 60 days prior to randomization
* Receipt of blood, blood products or plasma derivates one year prior to randomization
* Regular smoking of \>5 cigarettes per day within the past three months