cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Double-masked, Multicenter, Controlled Study of Intravitreal KH902 in Patients With Neovascular AMD

This study is designed to access the safety and efficacy of multiple injections of KH902 at variable dosing regimens in patients with CNV due to neovascular AMD.

AMD is the leading cause of severe vision loss in people over the age of 65 in the United States and other western countries. A quantity of documents indicate that neovascularization promoted by VEGF is main cause of visual acuity decline. Patients are starving for a new drug which can notably improve VA with less administration frequency and lower treatment cost.

The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The pre-clinical researches and phase I study show that KH902 is effective and safe in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF.

This study is designed to confirm the efficacy and safety of multiple injections of KH902 at variable dosing regimen in patients with CNV due to neovascular AMD. Based on the characteristics of KH902 and results from KH902 Phase I study as well as reference to clinical trials of similar drugs, it is determined that KH902 is administrated at 0.5mg/eye/time and 2.0mg/eye/time.

Eligibility Criteria:
Inclusion criteria:

* Signed the ICF; Age ≥ 50 years of either gender;
* Active primary or recurrent lesions with subfoveal or juxtafoveal CNV secondary to neovascular AMD in the study eye;
* Lesion size ≤ 12 disc areas in either eye;
* BCVA of the study eyes between 73 and 24 letters, inclusively, and the BCVA of fellow eyes ≥ 19 letters;
* Clear ocular media and adequate pupil dilation.
* If both eyes were eligible, only one was selected.

Exclusion criteria:

* History of vitreous hemorrhage, retinal detachment or macular hole, presence of retinal pigment epithelial tear, retinal macular traction or macular epiretinal membrane in the study eye;
* Subfoveal scar or atrophy in the study eye;
* Subretinal hemorrhage in the study eye;
* Uncontrolled glaucoma in either eye;
* Active inflammation or infection in either eye;
* Previous drug treatment, either anti-VEGF drugs or steroid derivatives, and/or, previous ophthalmologic operation or laser therapy in the study eye;
* History of surgery within one month preceding enrollment;
* Any uncontrolled clinical disorders;
* Patients of child-bearing potential do not adopted adequate contraception methods;
* Pregnant or nursing women;
* Patients need to exclude in the opinion of investigator.
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant

The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV (Pfirrmann MRI classification). "Post-market" means the device (i.e. the LISA implant) being used in this study has already obtained CE certification and is commercially available for use in the European market.

The LISA device consists of 3 components: A PEEK interspinous spacer, a polyester band, and a titanium blocker. The spacer is positioned between two adjacent spinous processes, the band is belted around the spinous processes and through the spacer, and the blocker is used to lock the band inside the spacer.

Medical Device manufacturers conduct "post-market" clinical studies in order to continuously evaluate the product scientifically and to comply with legal and ethical obligations. With these studies, the long-term safety as well as performance of their medical devices are assessed.

This study, which is initiated and sponsored by BACKBONE (LISA designer, developer, manufacturer and marketer), aims to evaluate the long-term safety and performance of the LISA implant for the treatment of lumbar degenerative disease and to evaluate the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patients Patient ≥18 years of age
* Patients with low-back pain caused by degenerative lesions of grade II, III and IV (Pfirrmann MRI classification)
* Failed conservative treatment for low back pain conducted for at least 6 months

Exclusion Criteria:

* Stage V degenerative disk lesions in Pfirrmann's MRI classification
* Spondylolisthesis
* Osteoporosis
* Non-specific back pain
* Modic 2 and Modic 3 changes
* L5/S1 segments affected
* Local or general infections that may compromise the surgical goals
* Major local inflammatory phenomena
* Pregnant and lactating Women
* Immunosuppressive diseases
* Bone immaturity
* Severe mental illnesses
* Bone metabolism diseases that may compromise the mechanical support expected from this type of implant
* Patient with worker's compensation, under litigation or on disability benefits
* Excessive physical activities
* Patients deprived of their liberty in accordance with respective national regulations
* Protected patients or patients not in a position to declare his or her consent in accordance with respective national regulations
Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010)

The primary objectives of the study are to characterize the pharmacokinetics (PK) of a single subcutaneous (SC) dose of tulisokibart (MK-7240) administered via autoinjector (AI) (Treatment A) and to characterize the PK of different concentrations of tulisokibart following SC administration of a single dose via vial/syringe (Treatments B and C). There is no formal hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* Is in good health
* Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive
* Has a weight between 50 and 100 kg, inclusive

Exclusion Criteria:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years or has had diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) in which the possibility of malignancy cannot be reasonably excluded following additional clinical assessments
* Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food
* Has a positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV); OR positive hepatitis B core antibody (HBcAb) with negative hepatitis B core antibody (HBsAb)
* Has a history of more than one episode of herpes zoster infection or history of disseminated herpes zoster infection
* Has a history of or current active tuberculosis (TB) infection; history of latent TB that was not fully treated or a positive QuantiFERON-TB test at screening
* Is a smoker and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 3 months of screening
* Consumes greater than 3 servings of alcoholic beverages per day
* Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months
Treatment for Young Adults With Anorexia Nervosa

Temple University is conducting a National Institute of Health funded research study designed to develop and refine a family-based treatment manual for young adults with Anorexia Nervosa as well as assess the feasibility of this out-patient psychotherapy.

Anorexia Nervosa (AN) is a serious psychiatric illness that occurs in an estimated 0.5 to 3.7% of women. The illness severely affects physical, emotional, and social functioning. The mortality rates associated with this severely disabling condition are higher than those for any other psychiatric disorder and substantially higher than those expected in the general population. Lower weight at presentation, longer illness duration, and alcohol abuse are associated with a higher risk of mortality.

Treatment-outcome for adult AN is poor with a quarter of adults with AN having poor outcome. In AN, promising outcomes are seen in family-based treatment (FBT) for adolescent patients who present between the ages of 12 to 18 with a short duration of illness. A manualized version of FBT has now been tested in several studies and case series, showing that well over 80% of participants had good or intermediate outcome at post-treatment. Despite its efficacy with adolescents, FBT has not been utilized with young adults.

The purpose of this study is to develop and refine FBT to promote weight gain in young adults with Anorexia Nervosa.

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV criteria for AN (restricting/binge-purge type) (BMI 16.0-18.5)
* Medically stable for outpatient treatment
* Availability of at least one supportive adult of choice in study client's environment
* Stable dose of psychotropic medication (8 weeks) for co-morbid condition

Exclusion Criteria:

* Associated physical illness that necessitates hospitalization
* Psychotic illness or other mental illness requiring hospitalization
* Current dependence on drugs or alcohol
* Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
* Previous Family-Based Treatment for Anorexia
Safety and Efficacy of PG101 for Dry Eye Syndrome

To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome

The topical product PG101 is expected to be efficacious in treating the symptoms of dry eye such as discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing. Two concentrations (0.25% and 1.0%) are included in the study to determine if there is a dose response effect.

Eligibility Criteria:
Inclusion Criteria:

* Be male or female of any race, at least 18 years of age
* Have provided verbal and written informed consent
* Be able and willing to follow instructions, including participation in all study assessments and visits
* Have a reported history of dry eye syndrome
* Have a history of use or desire to use eye drops for dry eye
* If a woman of childbearing potential, have a negative pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period
* Have a best corrected visual acuity of +0.70 logMAR or better in both eyes

Exclusion Criteria:

* Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1
* Be a woman who is pregnant, nursing or planning a pregnancy
* Have a known allergy and/or sensitivity to the test article or its components
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1
Aktiv i Sør: a Randomized Controlled Trial

The purpose of this regional parallel-group RCT was to assess the effect of a six-month tailored telephone and email based physical activity intervention on various measures of physical fitness and body composition in a sample of physically inactive adults. A total of 111 physically inactive adults (40-55yr) from Agder, Norway were randomly allocated to either an intervention group (IG;n=56) or a no-intervention control group (CG;n=55). The IG received tailored exercise recommendations, every two months by email or mail (print) in addition to motivational follow-ups every second week, alternatively by email and telephone. Primary outcome measures were various objective measures of musculoskeletal and cardiorespiratory fitness in addition to various measures of body composition, including waist circumference, body mass index and fat percentage, which were assessed pre- and post-intervention.


Eligibility Criteria:
Inclusion Criteria:

Participants were included in the study if they were

* healthy
* between the ages of 40-55
* residents of the Agder counties in Norway
* classified as physically inactive (not fulfill the recommendations for physical activity given by the Norwegian Directorate of Health
* within stage one to three of the five stages of change in the transtheoretical model stages of change

Exclusion Criteria:

Participants were excluded if they were

* Unhealthy/ill
* younger than 40 years or older than 55 years
* living outside the Agder counties in Norway
* allready fulfilling the national recommendations given by the Norwegian Directorate of Health
* within stage four or five of the five stages of change in the transtheoretical model stages of change
Verification of the Epidemiology and Mortality of Rare Diseases in Taiwan With Real-world Evidence

This study aims to explore the longitudinal incidence and prevalence trends of selected muscular and bone-related rare diseases, i.e., Familial Amyloidotic Polyneuropathy (FAP), Primary hyperoxaluria, Wilson's disease, Cystic fibrosis, Osteogenesis imperfecta, Porphyria, and Primary Paget disease, and analyze healthcare utilization.

A rare disease (RD) means any disease that affects a small percentage of the population. According to the "Rare Disease and Orphan Drug Act" in 2000, RD is defined as the prevalence of lower than 10,000 people in Taiwan, or with special circumstances, and announced after review by the "Review Committee for Rare Diseases and Orphan Drugs". There are many different causes of RD, such as genetic and infection. Although researchers have made progress in learning how to diagnose, treat, and even prevent a variety of RD, but there is still much to do because most rare diseases have no treatments. Due to the low morbidity rate and fewer numbers of people who suffer from RD, patients have been impacted by a severe pathology and insufficiently recognized, diagnosed, and cured. However, prevalence, healthcare utilization, and economic impacts of rare diseases based on real-world evidence are still unknown in the world, especially in Taiwan. In 2020, there were 226 diseases officially proclaimed as RD and 17,592 patients in Taiwan, and approved 108 orphan drugs and 40 special nutrients for treating those patients to reduce their financial burden.

Eligibility Criteria:
Inclusion Criteria:

* The RD patients were defined as at least two ambulatory care records or one inpatient record in one year with Familial Amyloidotic Polyneuropathy (FAP), Osteogenesis imperfecta, and Acute Hepatic Porphyria between 2009 and 2017.

Exclusion Criteria:

* The RD patients were diagnosed with Familial Amyloidotic Polyneuropathy (FAP), Osteogenesis imperfecta, and Acute Hepatic Porphyria before 2009.
Effect of an Antioxidant-rich Diet During Moderate Altitude Training

Athletes, especially in endurance sports, are at increased risk of oxidative stress and inflammation-related diseases and injuries. The production of reactive oxygen and nitrogen species (RONS) and inflammatory markers increase during exercise and especially during altitude training. Antioxidant supplementation is commonly used among athletes in the belief that it prevents oxidative stress and oxidative damage. A transient increase of RONS is however necessary to activate signaling cascades initiating training adaptation. Antioxidant supplementation has been shown to inhibit the exercise effects in several independent studies, possibly by interfering/reducing the signal cascades initiated by RONS. However, it is unknown whether a high intake of antioxidant rich foods can affect the amount of RONS, inflammation markers and/or training adaptation. The investigators want to examine whether an increased intake of natural antioxidants in the form of antioxidant-rich foods fruits, vegetables and berries, in line with the official Norwegian dietary advice can affect antioxidant status, immune function and training adaptation associated with altitude training in Norwegian elite athletes.


Eligibility Criteria:
Inclusion Criteria:

* National team athletes, summer endurance sports

Exclusion Criteria:

* Allergies in conflict with the intervention foods
* Use of medication that could affect training and performance
* Injuries that could affect training and performance
Hormone Estradiol Replacement Therapy Additional Herbals

The purpose of this study is to determine whether Hormone Replacement Therapy (HRT), safety studies are combined with herbal (garlic oil, rutin, and nattokinase) to reduce estrogen side effects. Making it safer when an endocrine supplement is needed for estrogen deficiency symptoms in menopausal and postmenopausal women.

Recent studies have proved :

-Garlic oil as garlic may reduce platelet aggregation, patients taking anticoagulant medication are cautioned about consuming garlic.

A 2013 meta-analysis concluded that garlic preparations may effectively lower total cholesterol by 11-23 mg/dL and LDL cholesterol by 3-15 mg/dL in adults with high cholesterol if taken for longer than two months. The same analysis found that garlic had a marginally positive effect on HDL cholesterol, no significant effect on blood triglyceride levels, and that garlic preparations were generally well tolerated with very few side effects.

* Nattokinase Nattō is made from fermented soybeans and has been eaten in Japan for about a thousand years. Nattō is produced by fermentation by adding the bacterium Bacillus natto to boiled soybeans. Nattokinase is produced by the bacterium acting on the soybeans . While other soy foods contain enzymes, it is only the nattō preparation that contains the specific nattokinase enzyme.
* Estradiol valerate is one of the most widely used esters of estradiol.
* Progesterone: Hormone replacement therapy. Progesterone is combined with 17-beta estradiol in the estrogen patch.

Eligibility Criteria:
Inclusion Criteria:

* Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in perimenopausal and postmenopausal women.
* Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

Exclusion Criteria:

* Known, past or suspected breast cancer;
* Known or suspected oestrogen-dependent malignant tumours (eg endometrial cancer);
* Undiagnosed genital bleeding;
* Untreated endometrial hyperplasia;
* Previous or current venous thromboembolism (deep venous thrombosis,pulmonary embolism)
* Known thrombophilic disorders (eg protein C, protein S, or antithrombin deficiency, see section.
* Active or recent arterial thromboembolic disease (eg angina, myocardial infarction);
* Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal;
* Known hypersensitivity to the active substances or to any of the excipients;
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents

The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.

Adolescents 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 I (IGF-I), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels GH. It is possible that deficiency of IGF-I, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in AN. The physiologic effects of rhIGF-I treatment in adolescents with AN had not been studied. The goal of this proposal was to investigate the acute effects of rhIGF-I on bone metabolism in adolescent girls with AN.

Specific Aim: It was hypothesized that adolescent AN patients, being IGF-I deficient, would respond to exogenously administered rhIGF-I with elevations in biochemical indices of bone turnover. Therefore, rhIGF-I was administered to AN patients by subcutaneous injection over 10 days with concomitant measurement of indices of bone turnover, and calcium regulatory hormones.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent girls with anorexia nervosa 12-18 years old

Exclusion Criteria:

* Pregnancy or nursing
* Hematocrit \< 30%, K \< 3 mmol/L
* Any illness (other than anorexia nervosa) known to affect bone and mineral metabolism such as diabetes, alcoholism, untreated hypo- or hyperthyroidism, or hyperparathyroidism
* History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who were on estrogen were still eligible to participate in the study.
The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines

The study is planned to show whether combined hypolipemic and antidiabetic therapy with various daily dosages influence the fasting plasma glucose, insulin sensitivity and proinflammatory cytokines in diabetic and dyslipidemic subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age (35-64yr)
* Primary hyperlipidemia (Total cholesterol \>200mg/dl, Triglycerides \>150mg/dl)
* Type 2 Diabetes
* For women:
* Menopause (\>12 months)
* Post hysterectomy
* Mechanical contraception
* Obtained informed consent

Exclusion Criteria:

* Secondary hyperlipidemia
* Morbid obesity (BMI\>40kg/m2)
* Alcohol or drug abuse
* Acute or chronic inflammation
* Congestive Heart Failure (NYHA III or IV)
* Unstable Ischaemic Heart Disease
* Moderate or severe hypertension
* Cancer in less than 5 years
* Chronic kidney disease (stage III-V)
* Liver failure
* Oral contraception
* Not compliant patient
* Laboratory results:
* alanine transferase (\>3xULN)
* creatine kinase (\>5xULN)
* haemoglobin (\<10/dl)
* PLT (\<100G/l)
* WBC (\<3,5G/l or \>10G/l)
Registry on Salvage Antiviral Treatment for Patients Experiencing ADV and / or CMV Reactivation Post Allogeneic HSCT

DESIGN:

Disease registry - non-interventional.

INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.

In this disease registry, data on approximately 120 allo HSCT patients who have received salvage treatment (second or later line) with any antiviral therapy for ADV and / or CMV post allogeneic HSCT will be documented; of these 120, at least 40 patients will have been treated with Cell Medica's immune reconstitution ACT as salvage therapy. The patients will be consented prospectively or retrospectively for collection of data. Data will be collected at baseline, 6 months and 1 year after commencement of salvage treatment. Retrospective data collection (for patients who underwent HSCT in 2010 or later) is permitted.

Eligibility Criteria:
1. Written informed consent
2. Physician requested salvage (defined as refractory to first, requirement for second line or greater) treatment for ADV and / or CMV reactivation post allogeneic HSCT.