cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021)

The goal of this study is to learn about the safety of 2 different amounts of sotatercept and if healthy Chinese people tolerate them. The study will also measure what happens to sotatercept in a person's body over time (pharmacokinetic or PK study).


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Is in good health
* Has a BMI≥18.0 kg/m\^2 and ≤28.0 kg/m\^2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has been treated with a sotatercept or luspatercept
Interval Aerobic Training and Continious Training

This research is comparing the effects of interval and continuous training which are the two types of aerobic training on persons' life quality and exercise capacity on coronary artery disease patients.

The participants are diagnosed coronary artery disease aged between 40- 80 and have no mental and physical disability to take part in research. The participants' demographic infos and clinical story were recorded. To evaluate exercise capacity we used the symptom-limited exercise test (ETT) and six minute walking test (6DYT). We evaluate the life quality by using Short Form-36 (SF-36).

All those evaluation tests are done before and after training. Participants are randomly divided into two groups, the first group took part in interval aerobic training (AAE) while the other group was joining in continuous training (SAE) three times a week during 6 weeks. In both groups, significant changes were found in ETT, test time and 6 DYT scores after the rehabilitation program (p\<0,05). But only AAE group have important statistical values comparing to SAE group on test time and 6DYT scores. After training SAE group showed significant statistical change in every SF-36 parameter, while AAE group showing significant values except energy/fatigue. AAE group have statistically significant changes comparing to SAE group on that parameters; physical function, role limitations due to physical function, role limitations due to emotional function and general health (p\<0,05). Consequently AAE is much more tolerable comparing to SAE and AAE is considered more effective in increasing some parameters. On the other hand, we observed that both training types can be used in cardiac rehabilitation safely.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed coronary artery disease
* aged between 40-80
* over %55 ejection fraction

Exclusion Criteria:

* mental and physical disability
* unstable angina pectoris
* thrombophlebitis
Endoscopic FHL Transfer for Acute Achilles Tendon Rupture

This observational study aims to evaluate the outcome of endoscopic flexor hallucis longus transfer (FHLt) in patients with acute Achilles tendon rupture (AATR).

This evaluation will be performed by examining the following parameters:

1. Patient satisfaction quantified with the Achilles tendon Total Rupture Score (ATRS). This is the primary outcome.
2. Complication rate
3. Ankle and Calf circumference compared to the contralateral healthy limb.
4. Passive and Active range of ankle motion compared to the contralateral healthy limb.
5. Hallux flexion force compared to the contralateral healthy limb.

Eligibility Criteria:
Inclusion Criteria:

* Signed Consent Form
* Acute Achilles Tendon Rupture (\<4 weeks)
* Underwent operative treatment with Endoscopic Flexor Hallucis Longus transfer
* More than 24 months postoperative follow-up
* Patients operated after 2015

Exclusion Criteria:

* Inability or Unwillingness to cooperate
* Medically unfit for examination
* Age less than 18 or more than 75 years
* Non-operative Management or any other Surgical Management
* Neglected Achilles Tendon Rupture (\>4 weeks)
* Bilateral Achilles Tendon Rupture
* Patients operated before 1.1.2015 or after 1.1.2023
* Comorbidities interfering with the secondary outcomes (e.g. Venous insufficiency resulting in lower limb excessive edema interferes with ankle and calf circumference, rheumatoid arthritis and/or previous foot and ankle surgery interferes with active and passive range of motion of the ankle, etc)
Feasibility of a First-Line Physical Activity Intervention After Stroke

The goal of this study is to explore a new intervention that supports physical activity within the first 6 weeks after stroke. All participants will complete assessments at weeks 0 and 7. During weeks 1 through 6, participants will use a Fitbit Inspire to track their step counts and meet with an occupational therapist one time per week. They will also complete weekly surveys. Physical activity levels will be measured using surveys and a wearable activPAL monitor 6 times during the study: Weeks 1, 3, 5, 7, 12, and 24.


Eligibility Criteria:
Inclusion Criteria:

* Stroke diagnosis confirmed by imaging
* Admitted to Fairview Health System (Minnesota) at the time of study enrollment or discharged to a community-based setting from Fairview Health System within 10 days before study enrollment
* Able and willing to participate fully in the study and provide informed consent or proxy consent with participant assent

Exclusion Criteria:

* Discharge anticipated to a transitional care unit, skilled nursing facility, or other non-community-based care setting
* Severe cognitive or communication impairments (inability to respond accurately to complete study screening questions or to provide informed consent or assent
* Comorbid neurological disorder (Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma, spinal cord injury, cerebral palsy)
* Comorbid cancer, currently undergoing chemotherapy or radiation treatment
* Received inpatient treatment or was hospitalized for psychiatric condition and/or alcohol or substance abuse within the past 12 months
* Current diagnosis of a terimnal illness and/or receiving hospice care
* History of allergic reaction to adhesives that precludes the use of an adhesive necessary for adherence to activPAL measurement
* Inability to speak, read, or understand English
* Concurrent participation in another rehabilitation intervention research study
* Resides more than 50 miles outside of the Twin Cities metropolitan area
* Investigator discretion for safety or adherence reasons
Effects of Hormonal Anabolic Deficiency and Neurovascular Alterations on Mortality in Male Patients With Heart Failure

Heart failure (HF) has been associated with chronic deleterious effects on skeletal muscle, endocrine system, vasculature and sympathetic nervous system. These alterations have a significant impact on quality of life, leading to a reduction in functional capacity and limited symptoms, which involve dyspnea and fatigue. The investigators tested the hypothesis that hormonal anabolic deficiency associated with neurovascular alterations may worsen the prognosis of patients with heart failure.

One hundred and fifty six patients have been enrolled so far. Methods were as described below:

* Muscle sympathetic nerve activity (MSNA) was directly recorded from the peroneal nerve using the microneurography technique ;
* All patients underwent symptom-limited cardiopulmonary exercise test performed on a cycle ergometer, using a ramp protocol with workload increments of 5 or 10 Watts per minute;
* Body composition measurements were performed using dual-energy X-ray absorptiometry (DXA);
* Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts;
* Blood samples were drawn in the morning after 12h overnight fasting. The laboratory tests included B-type natriuretic peptide (BNP; pg/mL) plasma level, serum sodium (mEq/L), serum potassium (mEq/L), creatinine (mg/dL), haemoglobin level (g/dL), high-sensitivity C-reactive protein (CRP; mg/L), lipid profile (triglyceride, total cholesterol, high-density lipoprotein, and low-density lipoprotein; mg/dL), and fasting glucose (mg/dL). Blood sample to assess hormone plasma levels were also drawn at the same time: total testosterone (TT), free testosterone (FT), sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyroid stimulating hormone (TSH) and insulin-like growth factor 1 (IGF1).

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years old;
* at least1 year of diagnosed HF;
* left ventricular ejection fraction (LVEF) lower than 40% measured by echocardiography;
* non-ischaemic and ischaemic aetiologies;
* compensated HF with optimal medication for at least 3 months prior the study;
* New York Heart Association (NYHA) class of I to IV.

Exclusion Criteria:

* patients with autonomic diabetic neuropathy;
* patients with chronic renal failure with haemodialysis;
* heart transplantation;
* presence of pacemaker;
* patients with muscular dystrophy (i.e. Duchenne muscular dystrophy);
* patients submitted to any hormonal treatment;
* history of cancer;
* ongoing infection;
* myocardial infarction with percutaneous coronary intervention or revascularization 6 months prior to the study entry.
Comparison of Doxycycline and Cefuroxime Axetil in Erythema Migrans

A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question. Evaluations of patients were conducted at baseline, 14 days and 2, 6, and 12 months after enrollment. Control subjects were evaluated at baseline and at 6 and 12 months. Subjective complaints that newly developed or intensified since the onset of erythema migrans or since the date of enrollment for controls were referred to as "new or increased symptoms"(NOIS).


Eligibility Criteria:
Inclusion Criteria:

* typical solitary erythema migrans as defined by the United States Centers for Disease Control and Prevention. In addition, patients with skin lesion \<5 cm in diameter were also included if they recalled a recent tick bite at the site of the skin lesion, had a symptom-free interval between the bite and the onset of the lesion, and reported an expanding skin lesion prior to diagnosis.

Exclusion Criteria:

* Lyme disease previously
* pregnancy or lactation
* immunocompromised
* serious adverse reaction to a beta-lactam or tetracycline drug in the past
* received an antibiotic with known anti-borrelial activity within 10 days
* multiple erythema migrans lesions
* presence of an extracutaneous manifestation of Lyme disease
Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking

comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking for treatment of documented pediatric keratoconus progression. The study patients are divided into 3 groups. Group A patient treated with standard cross-linking. Group B patients treated with accelerated cross-linking. Group C patients treated with transepithelial cross-linking.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patient less than 18 years old
* keratoconus stage I-III ABCD keratoconus grading system

Exclusion Criteria:

* age more than 18 years
* previous eye surgery
* current eye infection or pathology
Impact of Serious Pediatric Illness on Parent and Sibling Health

To estimate the impact of having a child with serious illness (SI) on the health and healthcare of other members of the child's family.

Although standard pediatric practice, when caring for a child with serious illness, is to provide support to the child's parents and any siblings, little quantitative information exists regarding what could be considered the "collateral impact" on other family members of having a child with serious illness in the family. This study seeks to provide such information, using existing claims data from the health insurance company, Cigna, to identify children with serious illness and then examining the health and health care of their family members. The investigators hypothesize that, compared to control families without a sick child, parents and siblings of children with serious pediatric illness (SPI) will have more new mental and physical health diagnoses, more new prescriptions, increased levels of Emergency Department (ED) and acute care services, and reduced levels of use of recommended chronic disease management for pre-existing conditions and of preventative services.

Eligibility Criteria:
Inclusion Criteria:

* Cigna customers as follows:

  1. Neonatal Intensive Care Unit (NICU) cohort: infants born at 30 weeks gestational age or less, or with a birthweight less than 1500 grams.
  2. Critical Congenital Heart Disease (CCHD) cohort: Newborns with critical congenital heart defects who undergo surgery by 12 months of life.
  3. Oncology cohort: Patients with new onset (not relapses) pediatric oncologic diagnoses including liquid, solid, and brain cancer.
  4. Severe Neurological Impairment (NI) cohort: Patients with severe neurologic impairments, associated with substantial functional impairment, relentless progressive deterioration, or substantially shortened life-spans.
* For each index patient in a particular SPI cohort, Investigators randomly identified up to four children of the same ages as the index patient but who do not have the specific SPI. The matching by age was as follows: in months if \< 3 years; and in years if age \> or = 3 years. Cigna then identified all family members, using both definitions of "family members" described above.

Exclusion Criteria:

-
Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures

The purpose of this study is to assess the differences between two different types of devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).

This trial is a prospective randomized controlled study including the treatment of AO/OTA 31-A2 fractures in 200 patients with 2 different surgical devices. 100 patients are treated with a Gamma Nail 3 (GN3) (Stryker) the other 100 patients with a Proximal Femoral Nail Antirotation (PFNA) (Synthes).

All surgeries are performed by trauma surgeons at a Level 1 University Hospital. One hundred patients are randomized to the gamma nail and 100 are randomized to the proximal femoral nail for treatment fixation. A 1:1 randomization is performed using sealed envelopes (200 in total), which are opened by the surgeon immediately before the operation.

Patients missing an informed consent form, incomplete chart, or showing a pathologic fracture are getting excluded from final comparisons.

Patients anthropometric data as well as pre-injury mobility assessments, and ASA will be documented. Furthermore the time from admission to going to surgery, surgery length, length of stay and mobility assessment at dischargement are recorded.

After surgery the stay in the hospital is documented precisely and patients are scheduled for next appointments 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.

Postoperative X-rays are measured precisely to determine the Tip-Apex Distance (TAD), the Parkers-Ratio, the Singh-Score and the Neck-Shaft-Angle of the injured and contralateral side. Rates of complications as cut-out and reoperation-rates are evaluated. All intra-operative complications are noted and included in the chart.

Eligibility Criteria:
Inclusion Criteria:

* AO/OTA 31-A2 fractures
* age between 18 - 100 years
* Signed written informed consent and agreement to attend the planned FUs
* Able to understand and read country national language at an elementary level

Exclusion Criteria:

* missing informed consent form
* pathological fracture
* incomplete patient record
* death within one month of intervention (surgery)
* prior surgery to the hip
* polytrauma
* any additional fracture
* any implant at the same hip
* infection
OxyNorm Capsules in Post-Operative Pain Study

The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.

To evaluate the efficacy and safety of oxycodone immediate-release capsules compared with morphine immediate-release tablets in hospitalized patients with moderate to severe pain following surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of either sex aged 18 to 80 years inclusive.
2. Patients who have given written informed consent to participate in the study.
3. Able and willing to communicate with the investigator and his/her staff.
4. Free of anesthesia as assessed through question and answer interaction with nurse at which time oral medication is indicated.
5. Reporting "moderate" or "severe" pain (VAS ≥ 4) related to surgery and requesting analgesics for pain relief.

Exclusion Criteria:

1. Patients have developed tolerance to or dependence on narcotic analgesics and/or alcohol.
2. Patients with ASA ≥ 3 .
3. Have any concomitant medical condition that would be adversely affected by analgesics or confound the quantification of analgesia, or could affect the absorption, metabolism or excretion of the study drugs in any clinically significant fashion.
4. Have known hypersensitivity to any of the study medications or related agents.
5. Have taken analgesic medications within three hours (wash-out) prior to dosing.
6. Have developed complications from the surgical procedure that would confound the study.
7. Have a history of severe iatrogenic adverse experiences.
8. Mothers nursing their infant during the 24 hours following study drug administration, or pregnant women.
9. Patient with Nothing Per Os (NPO) as stated in patient's chart or physician's order.
10. Surgery in patients with epidural anesthesia
11. Patients with Severe impairment of liver at preoperative stage (ALT, AST ≥ 1.5 times upper limit) and abnormal renal function.
12. Patients with medical history of recovering from abnormal surgery anesthesia.
13. Patients with medical history of hypertension (Systolic blood pressure ≥ 180Hg, Diastolic blood pressure 110Hg).
14. Patients with shock.
15. Patients with COPD.
16. According to investigator to determine, patients are in addition the inclusion criteria and exclusion criteria for any other reason than not suitable in this study.
Impact of Non-fasting on Anxiety in Cataract Surgery

The aim of this prospective study was to investigate whether non-fasting recommendation could reduce preoperative anxiety level, incidence of anesthetist interventions, and number of surgical complications in elective cataract surgery patients.

Fear of aspiration makes anesthetists reluctant to challenge standard pre-operative fasting guidelines recommending stopping eating solids and drinking clear fluid 6 hours and 2 hours, respectively before anesthesia. However, hunger and thirst exacerbates patients' anxiety, adversely impacts the patient's comfort and satisfaction, and enhances pain response leading to additional need for analgesia.

Patients undergoing non-invasive procedures requiring no or light sedation may benefit from non-fasting recommendations. The need for preoperative fasting in patients undergoing cataract surgery under topical anesthesia remains controversial. Patients are not fasted before standard cataract surgery under local anesthesia in many cataract centers, in accordance with the UK national guideline published in 2012. However, this practice is not supported by a high level of evidence from prospective clinical trials. So far, the lack of international professional consensus on the matter, local practices are based on institutional recommendations obviating the need for starvation in routine cataract surgery under topical anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Information and collection of patient consent
* Age greater than or equal to 18 years
* Affiliation to a social insurance
* Undergoing cataract surgery under topical anesthesia
* Intervention on the 1st eye

Exclusion Criteria:

* Refusal to participate
* Language barrier incompatible with the performance of a reliable assessment
* Behavior disorders
* Anesthesia other than topical
* Voluntary control disorder
* Intervention on the 2nd eye
* Taking psychotropic drugs.
* Legal protection regime
DAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia

Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-2, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment-resistant schizophrenia patients in a randomized, double-blind, placebo-controlled trial.

Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, many clinical trials on NMDA-enhancing agents were studied. Adjuvant NMDA-enhancing agents, including glycine, D-amino acids such as D-serine, and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms.

The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment resistant schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill the DSM-IV criteria of schizophrenia
* Treatment resistant: No satisfactory response to at least two kinds of antipsychotics
* Remain symptomatic but without clinically significant fluctuation and the antipsychotic doses are unchanged for at least 3 months
* Have a minimum baseline total score of 70 on the Positive and Negative Syndrome Scale (PANSS)
* Agree to participate in the study and provide informed consent

Exclusion Criteria:

* Meet DSM-IV criteria of substance (including alcohol) abuse or dependence
* Meet DSM-IV criteria of mental retardation
* Serious medical or neurological illness
* Pregnancy or lactation
* Inability to follow protocol