cyrilzakka/clinical-trials huggingface dataset:
Effect of a Novel Protein Supplement on Appetite in Older Adults

An acute randomized crossover trial comparing the effects of the whey hydrolysate, whey protein concentrate and placebo (still flavored water) on appetite and energy intake in older adults. Both low-dose whey-derived treatment and placebo will be administered 30 minutes prior to breakfast and lunch meals. Moreover, ghrelin secretion and activity will be monitored throughout the morning until the lunch time. Appetite will be assessed through visual analogue scale questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling,
* Age 60+ years
* Poor appetite (Simplified Nutritional Appetite Questionnaire (SNAQ) score \</=14, answer a, b or c to Q.1 on SNAQ or answer b, c, or d to CES-D question regarding poor appetite in the past week)
* BMI 20-25kg/m2

Exclusion Criteria:

1. Current medical condition or medication known to impact appetite or energy intake
2. Other medical condition that would impact study participation and outcomes, as judged by the study investigator.
3. Heavy smoker (\>10/day)
4. Inability to come to study centre
5. Currently participating in another intervention study
6. Lacking informed consent
7. Allergic to or unwilling to consume any of the study test foods
8. Loss of taste or smell associated with COVID-19
9. Unable to walk across a room
Benefits of Extracorporeal Shockwave Therapy to Reduce Spasticity in Stroke/CP

This Study will help to explain us that ExtracorporealShockwave therapy can reduce spasticity in Stroke Patient,help them to restore their abilities and ROM.Therapy reduces dependency rate of patient.Also seen this therapy shows reduction in spasticity of CP child population.Improving the motor recovery.

ESWT therapy increses molecular and immunological reactions,increase blood microcirculation and neurovascularization.It enhancing the neural proliferation of neural stem cell(NSC),which shows repair in brain function in CNS diseases.Extracorporeal shockwave can produce Nitric oxide in enzymatic and non enzymatic way which help, to reduce muscle spasm.Extracorporeal Shockwave reduce the exitibilty of motor neuron by vibratory stimulation of tendon and reduces tension.After 2 weeks ESWT muscle tension reduces increases range of motion reduces the pain.shock wave therapy appears to be effective in reducing spasticity levels irrespective of the age of the participants, the type of injury, and the tool used to measure the effect.ESWT change in motor neuron exitibilty \& also associated with the spastic muscle.

Eligibility Criteria:
Inclusion Criteria:

* 3rd stage of Stroke

Exclusion Criteria:

* Non spastic CP,1st stage of Stroke,Spasticity caused by injury,Newborn
Safety and Effectiveness of Integrative Korean Medicine Treatment for Traffic Accident During Pregnancy

The purpose of this study is to reveal the efficacy and safety of integrative korean medicine treatment for pregnant women who suffered a traffic accident. A retrospective chart review and follow-up were conducted.

From January 1, 2018 to April 22, 2022, pregnant women who visited an korean medicine hospital due to a traffic accident were subjected to a retrospective study of patient medical records and follow-up.

Medical records of selected patients will be analyzed, and telephone or internet surveys will be conducted for each patient. The survey questions are Numeric rating scale(NRS), Neck disability index(NDI) score, Oswestry Disability Index(ODI) score, Shoulder Pain and Disability Index(SPADI) score, The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) score, EuroQol 5-dimension 5-level(EQ-5D-5L) score and patient global impression of change (PGIC) score, etc.

Eligibility Criteria:
Inclusion Criteria:

* Patients who visited hospital due to symptoms caused by a traffic accident during pregnancy and received one or more korean medicine treatment as an inpatient or outpatient treatment
* Patients who understand the purpose and contents of the study and agree to participate in the study
* Patients with communication skills and mental/physical ability to respond appropriately to questionnaires

Exclusion Criteria:

* Patients under the age of 18 at the time of the first visit
* Patients who received treatment without being aware of pregnancy
* Patients who have undergone only consultation or Western treatment at the hospital
* Patients whose participation in the study is difficult for the researcher to judge
Epigenetic Regulation of BDNF in Schizophrenia

In this proposal, we will (1) detect the associations between BDNF and Trk B gene DNA methylation, histone modification, psychotic symptoms, obesity, suicide and antipsychotic drug responses in Taiwanese patients (2) discuss the possible mechanisms of epigenetic regulation of BDNF and Trk B in schizophrenia patients.

A total 160 subjects (80 subjects every year, including 40 healthy controls and 40 schizophrenia patients) will be recruited during a 2-year period. The first year, the baseline data of BDNF and Trk B DNA methylation, protein and mRNA levels in all subjects will be collected and the following 1 months data will also be collected in schizophrenia with antipsychotic drug treatments. The second year, the baseline data of BDNF and Trk B histone modification in all subjects will be collected.

Eligibility Criteria:
Inclusion Criteria:

-

1. The clinical screening and assessment in schizophrenic patients：

1. 40 schizophrenia patients will be recruited in psychiatric inpatients according to DSM-IV criteria (APA, 1994) by a structured interview (SCID). The assessment will be done by two senior psychiatrists. The intra-rater and inter-rater reliability will be done before this project started
2. age : 18-65 years old.
3. The patients had the ability to complete the written inform consent.。
4. The choice of antipsychotic drugs depended on the need of patients in natural treatment procedure. They included conventional drugs, eg.haloperidol 10-20 mg/day；SDA (serotonin dopamine antagonist) drug, eg. clozapine 100-400 mg/day or risperidone 3-6mg/day. The choice of the medication was according to the need of patients including previous responses and side effects.
5. PANSS (Positive and Negative Syndrome)(Kay, 1987,1988\&1989) for positive, negative symptoms and severity.
6. Check body mass index (BMI): if BMI\<24: normal; 24\<BMI\<27: overweight; BMI\>27: obesity (Taiwan criteria, 2004). If the patients were overweight or obesity, the lipid profiles would be done and we would consult the experts to assess these patients. The condition for diet control and daily activity will be observed. If the condition was extremely abnormal, the case will be excluded.
7. Suicide behavior in tis study includes complete suicide and suicide attempt.

Exclusion Criteria:

1. The patients had systemic diseases, including metabolic, heart, and liver diseases。
2. The patients had received any drugs before entering this protocol.
3. The patients were heavy smokers or dependent on alcohol.
A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

The purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (ICP) following cardiopulmonary bypass (CPB) using optic nerve sheath diameter (ONSD), measured by non-invasive ultrasound. As direct measurements of ICP are not feasible following CPB, ONSD will be used as a correlate of ICP. ONSD has been shown to be effective in the ICU and emergency room setting for detecting increased ICP and is an accepted standard for such measurements. The primary hypothesis is that changes in ICP occur following CPB without clinically appreciable signs and symptoms. These changes in ICP will be reflected by changes in ONSD. If there is a significant incidence of sub-clinical cerebral edema and increased ICP postoperatively, these findings may impact postoperative hemodynamic and ventilation goals and techniques.


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 18 years of age undergoing cardiac bypass.

Exclusion Criteria:

* None
Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon

Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter

Experimental intervention: Predilatation of coronary ISR with POBA followed by a sirolimus coated SeQuent®SCB balloon balloon (sirolimus 4.0 μg/mm²)

Control intervention: Predilatation of coronary ISR with POBA followed by a paclitaxel coated SeQuent®Please balloon or SeQuent®Please NEO balloon (paclitaxel 3.0 μg/mm²)

Duration of intervention per patient: minutes

Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months clinical follow up

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study
* Patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥50% and positive functional study) including margin-stenosis with max 5 mm distance to the stent

Exclusion Criteria:

* Chronic renal insufficiency with serum creatinine levels \> 2.0 mg per deciliter
* Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication
* Concomitant medical illness associated with a life-expectancy of less than two year
* Lesion length (ISR) \> 35 mm, reference vessel diameter \< 2.5 mm
Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma

Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.

Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells \<10% in the primary tumor after nephrectomy.

Study Design:

Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs.

Sample Size: 20 participants.

Patient Grouping: Non-randomized.

Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

Voluntary consent to participate in this study and signing of an informed consent form.

Male or female participants aged ≥18 years and \<80 years. Histologically diagnosed with clear cell carcinoma or predominantly clear cell renal cell carcinoma.

Clinical stage determined by CT or MRI: anyTN1M0 or anyTN0M1; IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs; and the primary tumor (unilateral or bilateral) is resectable.

ECOG performance status: 0 or 1. No clinically significant cardiac, bone marrow, hepatic, or renal function abnormalities.

A willingness and ability to comply with testing and follow-up procedures.

Exclusion Criteria:

Non-clear cell carcinoma. Severe liver or kidney dysfunction, or other severe diseases. Immune deficiency, organ transplantation, or autoimmune diseases. Severe central nervous system diseases. Other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.

Unable to comply with regular follow-up visits due to psychological, social, family, or geographical reasons.
3D Printed Custom Applicators for HDR BT (DISCO)

Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. This study is a Phase IIa non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3D-printed custom applicators.

Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. Current workflows for designing and constructing custom applicators with wax moulds are complex, time consuming and can result in a device that fails to meet original design specifications dictated by the planning system. In contrast, 3D-printed custom applicators provide the ability to design and print patient-specific devices that match optimal design specifications. The workflow for 3D-printed applicators is also more efficient with lower turn-around time and labour/equipment costs, and ensures a more robust product for treatment. Despite these advantages there is currently no radiotherapy department offering 3D printed custom applicators at present. This study will investigate the feasibility of successfully treating gynaecological cancers with 3D-printed custom applicators.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Patients indicated for intracavitary brachytherapy
* FIGO stage I-IVA
* ECOG 0-2
* Primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent gynaecological cancer

Exclusion Criteria:

* Pregnancy
* Patients contraindicated for brachytherapy
* Inflammatory bowel disease/history of adhesions/bowel obstruction
* Renal transplant/horseshoe kidney
* Patients with significant LVSI or pelvic sidewall invasion
* Patients requiring interstitial brachytherapy implants
Clinical Empirical Research of ARDS

According to the ARDS Berlin definition, patients with severe concurrent invasive mechanical ventilation were selected, and clinical data and prognosis were collected. Samples such as blood and balf were collected for analysis based on changes in the condition.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the Berlin definition of ARDS and require invasive mechanical ventilation. ARDS diagnostic criteria: according to the Berlin definition, Chest radiograph shows patchy shadows in the lungs; Respiratory failure cannot be completely caused by heart failure or excessive fluid infusion
2. ARDS onset ≤ 3 days when included in the study
3. Patient PaO2/FiO2 ≤ 200mmHg when included in the study

Exclusion Criteria:

* 1) Patients with intracranial hypertension, pleural fistula, pneumothorax, HIV, HBV, HCV

  2) Age\>85 years old or\<18 years old

  3) Pregnant patients

  4) Severe hemodynamic instability (vasopressor increase\>30% in the first 6 hours, or Norepinephrine\>0.5 mg kg/min)

  5) Patients unable to perform EIT ventilation and/or perfusion testing (unable to perform internal jugular vein catheterization, Hypernatremia, chest malformation, active implant device, unstable spinal injury or fracture, skin lesions opposite the EIT monitoring area)

  6) Patients with abnormal esophageal anatomical structure and inability to indwelling gastric tubes

  7) Disagreement for inclusion in this study
B14 Meningococcal Carriage in Seine-Maritime Population: Prevalence Study and Search of Risk Factors

Our main objectives are to evaluate the importance of meningococcal carriage and to determine the predisposing factors


Eligibility Criteria:
Inclusion Criteria:

* Living in the area of Dieppe
* Parental authority assent if necessary

Exclusion Criteria:

* Child under supervision
Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura.

Migraine with aura (MA) is an independent risk factor for stroke and is associated with silent brain infracts and T2 white matter hyperintensities on MRI. Previous studies using Transcranial Doppler (TCD) have shown an impairment of cerebral autoregulation in MA patients. Studies with positron emission tomography have demonstrated an activation of brain stem areas during migraine attack. An increased density of brain stem grey matter as measured on MRI with voxel based morphometry (VBM) has been found in MA patients. As brain arteries and arterioles are innervated by ascending tracts from aminergic brainstem nuclei, th study hypothesize a negative correlation between the density of brainstem nuclei and the efficiency of cerebral autoregulation in MA patients compared with controls.

Brainstem grey matter density will be studied with a MRI Philips 3 Tesla with a 32-channel antenna and voxel-based morphometry (VBM) cerebral autoregulation will be measured in the time domain using Transcranial Doppler (TCD) and the Mx method.

MA patients will be studied in a headache-free period. MRI and Transcranial Doppler (TCD) are non-invasive technics and will be performed on the same day.


Eligibility Criteria:
Inclusion Criteria:

* Migraine with aura patients : fulfilling the International Classification of Headache Disorders-3 beta criteria of MA
* Control group : Gender- and age-matched subjects without history of migraine with or without aura or any other headache

Exclusion Criteria:

* History of illness or injury of central or peripherical nervous system
* Previous history of a disease potentially impairing cerebral autoregulation (diabetes, sleep apnea syndrome, uncontrolled hypertension, cardiac arrhythmia, hearth failure, carotid stenosis)
* Contraindications related to MRI
* Absence of temporal acoustic window
* Pregnancy
M.I.P.O. vs Intramedullary Nailing in Tibia Fractures

The investigators are comparing two methods of standard treatments in distal tibial fractures. locked plating (M.I.P.O. technique) with intramedullary nailing.

the investigators are hypothesizing that M.I.P.O group is superior to nailing in fractures of the distal third of the tibia.

The kind of plates the investigators are comparing are the Locked plates form Synthes ® using the minimally invasive technique vs the Expert Tibial Nail® from Synthes ®

Eligibility Criteria:
Inclusion Criteria:

* Males and Females aged from 18-60 years
* Closed Tibia Fracture
* Tibia Fracture Müller AO Class 43-A

Exclusion Criteria:

* Intra-articular Fractures
* Open fractures
* fracturesSubjects with documented Marfan's syndrome or Ehlers-Danlos syndrome or Hajdu-Cheney syndrome.
* Post organ transplant patients (except Cornea transplant)
* Subjects on immunosuppressive medications
* Subjects with diagnosed with

  * Osteogenesis imperfecta
  * Osteopetrosis
  * Paget disease of bone
  * Renal osteodystrophy
* Subjects with diagnosed neoplasms or mitotic illnesses
* Subjects receiving growth hormone
* Unable to comply with postoperative rehabilitation e.g. head injury
* Impending compartment syndrome
Angiotensin Converting Enzyme (ACE2), Brain, Gut Dysbiosis in Pulmonary Hypertension

Pulmonary arterial hypertension (PAH) is fatal with right heart failure due to raised pulmonary vascular pressure. Gut dysbiosis was identified in animals with pulmonary hypertension. Deidentified human samples will be tested for gut dysbiosis in PAH, circulating bacterial metabolites and markers of inflammation and gut leakiness. The gut microbiome and circulating metabolites, markers of inflammation and gut leakiness of PAH patients and healthy subjects will be compared in deidentified fecal samples and blood.

Stool samples will be collected from people with no, mild-moderate or severe pulmonary arterial hypertension. Bacterial DNA will be extracted from the feces and sequenced by whole genome sequencing (shotgun sequencing). The DNA sequences will be used to identify the bacteria present in the feces, and to model the functions of the gut microbial community in each of the three groups. This will test for gut dysbiosis in pulmonary arterial hypertensive patients compared to healthy subjects. Gut dysbiosis is a condition where the gut bacterial communities are unbalanced and has been implicated in disease processes.

In subjects recruited in the USA, blood samples will be tested for markers of gut leakiness and inflammation as well as gut bacterial metabolites found in the circulation.

Eligibility Criteria:
Inclusion Criteria:

* severe, mild-moderate or no pulmonary arterial hypertensive subjects

Exclusion Criteria:

* Patients with pulmonary hypertension due to left heart disease, lung diseases and / or hypoxia, chronic thromboembolic pulmonary hypertension, and pulmonary hypertension with unclear multifactorial mechanisms.
QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study

Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.

This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.

Eligibility Criteria:
Inclusion Criteria:

* Residual specimens (minimum 500μL) of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing Specimen that have not undergone more than 3 freeze/thaw cycles.

Exclusion Criteria:

* Specimens not fitting criteria outlined above.
* CSF obtained from an external ventricular drain or shunt source.
* Lack of clear subject identification or label on residual banked CSF specimen.
* Specimen has been centrifuged.
* Obvious physical damage of banked residual specimen.
* Repeat specimens from the same subject.