cyrilzakka/clinical-trials huggingface dataset:
Retention of Whole-body Training Effects on Ambulatory Function in Children With Cerebral Palsy

This study will evaluate the retention effects of a four-week whole-body vibration training intervention in children with Cerebral Palsy. The primary outcomes for this study are gait function, including Timed Up and Go and the two-minute walk test. Secondary outcomes of this study include lower extremity gait function, coordination, and gait variability. For this study, a total of 10 children with Cerebral Palsy (CP) will be recruited with 5 being randomly placed into an experimental group and 5 being randomly placed into a control group. Each participant, regardless of group, will complete pre-, post-, and retention testing, with a four-week whole-body vibration training intervention between the pre- and post-testing. The four-week whole-body vibration training will include three visits per week, with the experimental group receiving a vibration stimulus while standing on a vibration platform. Vibration sessions will consist of three-minutes of vibration, followed by three minutes rest, completing this cycle three separate times. The control group will follow a similar pattern, but rather than experiencing vibration, they will hear a sound of the vibration platform through a speaker. Once the four-week training session is finished, participants will return after a three-month retention period to determine whether ambulation function was retained.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cerebral Palsy
* Ability to walk independently

Exclusion Criteria:

* Musculoskeletal injuries or conditions (other than Cerebral Palsy) which alter their independent walking ability
Comparison of Vagus Nerve-preserving RADG and Conventional RADG for AGC

Through comparative observation of robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve) operative and postoperative indicators, and evaluating the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.

Compare the robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve). Observe the operative and postoperative indicators, and evaluate the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged less than 70 years and more than 18 years;
2. Underwent gastroscopy and biopsy - preoperative definite for advanced gastric cancer invasion depth is T2, T3;
3. The lesion is in the middle and lower stomach;
4. Magix routine upper gastrointestinal barium meal, endoscopic ultrasonography, abdominal CT and chest X ray examination, clearly no nerve invasion and adjacent organ invasion and distant metastasis;
5. The preoperative examination of lung, liver, heart, renal insufficiency, surgical contraindication;
6. The preoperative abdominal CT or abdominal ultrasound without biliary disease and gallbladder stones;
7. No history of gastrointestinal dysfunction and other malignant tumor history;
8. The patients voluntarily participate in the study and signed informed consent.

Exclusion Criteria:

1. Older than 70 years old or because of chemotherapy surgery and complications after intolerance;
2. The vagus nerve invasion or invasion of adjacent organs or confirmed the presence of distant metastasis;
3. Have a history of abdominal surgery or chemotherapy before surgery;
4. The recent cardiovascular hemorrhagic or ischemic disease;
5. The amount of abnormal glucose tolerance or diabetes;
6. Not suitable for robotic surgery, such as body short that mechanical arm can not have enough activity range;
7. The history of biliary calculi or gastrointestinal dysfunction;
8. The other is not suitable for receiving robot surgery;
9. Participated in other clinical studies in the last month;
10. Other researchers not suitable for participation in the study of (HIV infection and intravenous drug addict), or other effects of this clinical study results analysis of the situation.
PureGen: Radiographic Analysis of Fusion for ACDF

The purpose of this study is to evaluate the rate and quality of spinal fusion utilizing PureGen Osteoprogenitor Cell Allograft in Anterior Cervical Discectomy and Fusion (ACDF).

This is a prospective, multi-center, post-market, observational study assessing subjects undergoing cervical interbody fusion surgery to treat cervical degenerative disc disease (DDD)

Patients diagnosed with cervical degenerative disc disease will be screened for enrollment based on inclusion and exclusion criteria outlined in this protocol. Subjects who are successfully screened and sign an informed consent will undergo ACDF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), a radiolucent cervical interbody spacer, and Trestle or Reveal Anterior Cervical Plating System (plate and screw fixation system).

Subjects will be followed at 6- weeks, 3-, 6-, and 12-month post-operative visits. Standard radiographs will be taken at these visits to assess fusion rate and quality. SF-12, NDI and VAS self assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography scan will be taken at the 6 month post operative exam to further assess rate and quality of fusion. A conditional 12-month post operative CT may also be taken. Procedure related and device related adverse events will be monitored throughout the study.

Outcome data will be compared to published and/or retrospective data for the standard of care for DDD patients undergoing ACDF.

Eligibility Criteria:
Inclusion Criteria:

* Persistent neck and/or arm pain consistent to symptomatic cervical degenerative disc disease
* Moderate Neck Disability Index
* Unresponsive to conservative treatment for at least 6 weeks

Exclusion Criteria:

* More than 4 levels requiring surgical treatment
* Prior failed fusion surgery at the index level(s)
* Systemic or local infection in the disc or cervical spine, past or present
* Active systemic disease
* Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
* Known or suspected history of alcohol and/or drug abuse
* Involved in pending litigation or worker's compensation relating to the spine
* Pregnant or plans to become pregnant during the duration of the study
* Insulin-dependent diabetes mellitus
* Life expectancy less than study duration
* Any significant psychological disturbance that in the opinion of the Investigator could impair consent process or ability to complete self-assessment questionnaires
* BMI greater than 40
* Undergoing chemotherapy or radiation treatment, or chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs
* Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO).
Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis

Bruxism is a non-functional repetitive jaw-muscle activity characterized by grinding or clenching the teeth. Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism.

Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Although the etiology is not known exactly, it has been suggested that bruxism is a multifactorial disorder. Periodontitis, a prevalent inflammatory condition affecting the periodontium, has been linked to bruxism in several studies. The coexistence of bruxism and periodontitis poses unique challenges in clinical management of periodontitis. Also, as periodontitis became chronic, the occurrence of depression increased. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism. Therefore, this study aims to investigate impact of subgingival instrumentation on psychological distress and mental health status in bruxers with periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients
* Patient having periodontitis with bruxism
* Age between 30-50 years

Exclusion Criteria:

* History of mental health disorder
* History of systemic disease
* History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
* Pregnant or lactating females
The Effect of Vitamin B3 on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men

In animals, treatment with vitamin B3 improved insulin sensitivity and substrate metabolism. It is currently not know if vitamin B3 has the same positive effects in humans. In the current study the effect of a 3 month treatment with vitamin B3 on insulin sensitivity and substrate metabolism in obese men will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* written signed consent
* male
* BMI\>30 kg/(m2)
* age: 40-70
* no medication
* non-smoker

Exclusion Criteria:

* endocrine disease
* other severe disease
* high daily activity level (\>30 min / day)
Survey Conducted Among Early Breast Cancer Patients Treated With Arimidex for Evaluation of Treatment Adherence

The aim of this study is to assess the patient's perception about and willingness to take his or her medication and the influencing factors interfering with taking medication.


Eligibility Criteria:
Inclusion Criteria:

* Early breast cancer
* Post menopausal
* Adjuvant hormonal Arimidex therapy
Quantitative T1rho Magnetic Resonance Imaging in Healthy Subjects

T1rho imaging is a new MRI technique that has strong potential in neuroimaging. This technique does not require exogenous contrast agents and has high spatial resolution.

In this study we aim to characterise the normal appearance of T1rho in the brain parenchyma in healthy participants. T1rho values will be measured in normal brain structures.


Eligibility Criteria:
Inclusion Criteria:

- Male and female volunteers greater than or equal to 18 years of age

Exclusion Criteria:

* Subjects with a contraindication to magnetic resonance imaging such as the presence of metallic implants, claustrophobia and pregnancy.
* Subjects with previous severe allergic or anaphylactoid reaction to a gadolinium contrast agent, or contraindication to contrast gadolinium administration, such severe renal disease or acutely deteriorating renal function, who would be at risk of nephrogenic systemic fibrosis
* Subjects who are unable to tolerate the scan without moving the head as a result of symptoms such as tremor, spasticity, involuntary movements and spasms, cognitive impairment, coughing, and shortness of breath.
Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction and Exercise Capacity at High Altitude

The objective of this study is to determine if single dose administration of inhaled iloprost will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve arterial oxygenation at rest and during exercise at high altitude.

Three major pathways in addition to oxygen modulate pulmonary vascular tone: 1) nitric oxide, 2) endothelin, and 3) prostacyclin. Considerable animal data support the role of the prostacyclin pathway in modulating hypoxic pulmonary vasoconstriction. In humans, prostacyclin and its analogs are important therapeutic agents in the treatment of pulmonary arterial hypertension (PAH). Despite the animal data and human data in PAH there is very little information about the use of iloprost to relieve hypoxic pulmonary vasoconstriction in healthy humans. Inhaled iloprost is an ideal agent to study the prostacyclin pathway due to its short duration of action (30-90 min) and elimination half-life of only 20-30 min. Individuals already participating in the Nepal Medex 2008 trip will be invited to participate in this research. Participants will be healthy active females or males, between 18-80 years of age, without known pregnancy or liver disease, who have a readily measurable tricuspid regurgitant velocity by Doppler echocardiography. If possible, we will attempt to identify a cohort of HAPE susceptible patients. Participants will undergo evaluation both at sea level (baseline) and at high altitude. Baseline (low altitude) testing will be performed in Bangor, North Wales, UK, and will include evaluation of pulmonary artery systolic pressures, cardiac output, and oxygen saturation at rest and during submaximal exercise before and after inhalation of iloprost. This strategy will then be repeated at an altitude of approximately 5000 meters in the Dhaulagiri region of Nepal.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 - 80 years
2. Healthy physically active males or females
3. Have readily measurable tricuspid regurgitation (TR) peak systolic velocity by continuous wave Doppler ultrasound

Exclusion Criteria:

1. Unable to measure TR velocity
2. Known liver disease
3. Pregnancy
4. Nitrates, cyclosporin, glyburide or other medications that in the opinion of the investigators could place subjects at increased risk of complications
5. Any other medical condition that in the opinion of the investigators would place the subject at high risk
An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth

This study aims to investigate the effects of an early intervention (joint observation and video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who have given birth to a very premature baby will be randomly allocated to either the early intervention or usual care whilst the infant is still hospitalized. Participants will be followed up at one month and six months. It is predicted that participants who received the early intervention will report higher maternal parenting self-efficacy than those who are not.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of very preterm infants born between 28 and 32 weeks of gestation
* Infant aged up to 8 weeks

Exclusion Criteria:

* Do not speak French sufficiently well to participate in assessments
* Have established intellectual disability or psychotic illness
* Infant too instable regarding hemodynamic or respiratory functioning (severe brady apnea, more than 30% oxygen)
Diagnostic Efficacy and Prognostic Value of 18F-FDG PET/CT (MR) in Pediatric Solid Blastoma

the primary histologic origin of extracranial solid tumors in children is malignant embryonic cells, including Neuroblastoma (NB) , Hepatoblastoma(HB), and kidney, wilms' tumor(WT). Their main clinical symptoms are large abdominal masses, the most common lymph node metastasis . NB accounts for 15% of childhood cancer deaths, but some low-risk NB can disappear on its own. The International Neuroblastoma Risk Group Staging System (INRGSS) was used to determine Risk before NB treatment, whereas the INRGSS was entirely based on the Neuroblastoma diagnosis, illustrating the importance of imaging in the assessment of NB.18F-FDG is the most commonly used agent in PET imaging of tumor. It can reflect the glucose metabolism of tumor and is widely used in the diagnosis, staging, evaluation of curative effect and prognosis prediction of tumor In this study, the investigators retrospectively analyzed 18F-FDG PET/CT or PET/MRI images from patients with NB, HB, and WT. The investigators sought to assess whether these images provide useful information for diagnosis and prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. age \< 18 years,
2. have pathological results or definite clinical diagnosis as the gold standard.

Exclusion Criteria：

1. had surgery or chemotherapy before imaging,
2. accompanying other tumors,
3. diabetic patients or patients with fasting blood glucose ≥ 200 mg/dL.
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)

This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).


Eligibility Criteria:
Inclusion Criteria:

* Male and female Japanese participants ≥20 years of age
* Diagnosis of chronic kidney disease (CKD) based on an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m\^2)
* Hemoglobin (Hb) ≤10.5 grams per deciliter (g/dL)
* Not currently being treated with dialysis and not expected to start dialysis within 3 months of screening

Exclusion Criteria:

* Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
* Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
* Red blood cell transfusion within 4 weeks prior to or during screening
* Intravenous iron within 4 weeks prior to or during screening
* Any use of erythropoiesis-stimulating agents within 6 weeks prior to or during screening
Sleep Duration Required to Restore Performance During Chronic Sleep Restriction

The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase.

The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. Inpatient sleep and performance data will be collected from healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Prescription medications
Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI

The purpose of this study is to determine which from the four combinations tirofiban+sirolimus eluting stent (SES), tirofiban+bare metal stent (BMS), abciximab+SES, abciximab+BMS is the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.

The combination abciximab plus bare metal stent (BMS) is currently considered the standard therapy for AMI. The use of sirolimus eluting stent (SES) is related to a reduction of the need for urgent target vessel revascularization (TVR). With current acquisition prices for abciximab and SES, replacing abciximab with tirofiban, administered as a single high-dose bolus (SHDB) regimen, is a promising strategy that would preserve financial resources. In a recent study the combination tirofiban and SES resulted to be associated to an overall lower major adverse cardiovascular events (MACE) rate with respect to the abciximab plus BMS. However, since no conclusion can be drawn yet regarding the relative contribution of a specific GP IIb/IIIa inhibitor or a stent type with respect to the other, the combination of abciximab and SES may be associated to an even lower event rate with respect to SHDB tirofiban and SES, thus offsetting the higher initial cost.

Comparison(s): four strategies (SHDB tirofiban + BMS, SHDB tirofiban + SES, abciximab + BMS, abciximab + SES) are compared to determine the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* ST segment elevation myocardial infarction
* Schedule for primary percutaneous coronary intervention
* Informed consent

Exclusion Criteria:

* Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current acute myocardial infarction or within 1 month before it
* History of bleeding diathesis or allergy to the studies drug
* Major surgery within 30 days
* Limited life expectancy, e.g. neoplasms, others
* Pregnancy
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female Volunteers

This trial will be conducted in the United States of America (USA). The aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between November 2007 and April 2008).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 30.0-39.0 kg/m2 (obese)
* Females who consent to using double barrier method of contraception, are post-menopausal and older than 50 years, or have had total hysterectomy

Exclusion Criteria:

* Clinically significant diseases
* Blood pressure greater than 140/90 mmHg
* Evidence of depression
* Recent diet attempts, treatment with diet drugs (within 3 months)
* Liposuction or other surgery for weight loss within the last year
* Evidence of eating disorders (bulimia, binge eating)
* Restricted diets (Kosher, vegetarian)
* Smoker or history of drug or alcohol abuse
* Females of childbearing potential: positive pregnancy test
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)

The purpose of this study is to evaluate the pharmacokinetics (PK) of N-hydroxycytidine (NHC) following a single oral dose of molnupiravir in participants 18 to 75 years (inclusive) with moderate hepatic impairment and healthy matched controls.


Eligibility Criteria:
The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has a BMI ≥18.5 and ≤35 kg/m2
* Diagnosis of chronic (\>6 months) stable Hepatic Impairment (HI) with features of cirrhosis due to any etiology (Moderate HI arm only)
* Has a score on the Child-Pugh scale ranging from 7 to 9 (Moderate HI arm only)
* In good health (except for Moderate HI)

Exclusion Criteria:

* Anticipated survival of \<3 months (Moderate HI arm only)
* Received antiviral and/or immune modulating therapy (Moderate HI only) for Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) within 90 days prior to study start
* History of clinically significant abnormalities or diseases (Healthy matched arm only).
* History of cancer
* Major surgery and/or donated or lost 1 unit of blood
* Taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month (Moderate HI arm only) and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 8 hours after administration of the study drug.