cyrilzakka/clinical-trials huggingface dataset:
Hydration Factor Study for the Stayhealthy BC3

This was a pilot study to validate the BC3 hydration factor which will be important for determining how well this value represents hydration status compared to assessment of total body water by D20.

The BC3 body composition analyzer is manufactured by Stayhealthy. It is a handheld, noninvasive bioelectrical impedance device. When held, the BC3 sends an electrical impulse through the body to determine body fat, lean mass, and total body hydration. Bio-impedance devices measure the change in electrical resistance in body tissues by using a detectable electrical signal that passes through the body. The method is based on the principle that lean body mass contains virtually all the water and conducting electrolytes in the body and provides a good electrical pathway. In contrast, fat or fat-containing tissues produce a poor electrical pathway. By inducing a low-energy, high-frequency signal, a measurement of the baseline resistance to flow of electrical current can be assessed. The resistance measurement relates directly to the volume of the conductor. Through repeated measurements and identifying other parameters (i.e. gender, weight, age and height) proprietary equations were developed that determine total body water, lean mass, and % body fat.

The purpose of this study is to validate the calculated hydration factor produced by the BC3 bioelectrical impedance device. If this value is valid and comparable to the gold standard (D20) then this hydration factor will offer a very quick and inexpensive method to determine total body hydration status using a hand-held bioelectrical impedance device.

Eligibility Criteria:
Inclusion Criteria:

• Men and women 18-80 years of age

Exclusion Criteria:

* Acute illness (infection, recent surgery, trauma).
* Pregnancy
* Pacemaker or defibrillator
Comparison of the Effects of Lower Limb Immobilisation With Cast and Orthosis

In this study we are going to measure the blood flow in the lower limbs under cast immobilisation and also under mobilisation with an orthosis. The aim is to evaluate how the aforementioned modalities affect the blood flow and also to compare between the two.

Background: Lower limb immobilisation, for example after an Achilles tendon rupture, is known to be a cause for DVT, partly due to blood stasis. VACOped is a weight-bearing orthosis with adjustable range of motion of the ankle which is used in our department in patients operated for Achilles tendon rupture.

Aim: To assess the effects of a) lower leg casting in equinus without loading and b) application of the aforementioned orthosis with full weight baring in blood flow and microcirculation in the lower limbs.

Study Plan: Ten healthy individuals are planned to be recruited for this study. Blood flow in the Right popliteal will be measured with vein before, 30 and 60 min after the application of the cast or orthosis (alternate order between consequent individuals) with Duplex Ultrasound. The orthosis will be set to allow for ankle plantarflexion restricted between 15 and 30 degrees. Tissue oxygen saturation in the lower limbs will also be measured using a somatic regional oxymetry modality, INVOS, with adhesive sensors applied on each leg above the soleus.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Severe cardiovascular or renal disease causing pitting oedema
* Previous operation in the lower limbs affecting the vascular or lymphatic system
* Pregnancy
LTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria

The project aims to test the feasibility, acceptability, cultural appropriateness and effectiveness of LTP+CaCBT for treating postnatal depression and to enhance the mental health and wellbeing of mothers and their children in the low-income areas of Jos Nigeria. This project also aims to provide primary healthcare workers with culturally sensitive requisite skills and support to embed the proposed intervention into routine care practice and increase access to evidence-based intervention.

Participants who scored 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS) would be recruited randomly assigned into two groups in each of the four primary health care (PHC) facilities designated for the present study. Groups one will receive the LTP+CaCBT treatment - the intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes). Groups two will receive routine treatment as usual (TAU) currently available in the PHC facilities (e.g. antidepressants) in the selected communities. Each group will comprise of approximately 10 mother-child pairs.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* A mother with a child (0-3 years)
* Able to provide full consent for their participation
* A resident of the trial catchment areas
* Able to complete a baseline assessment
* Score 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS).

Exclusion Criteria:

* Less than 18 years
* Medical disorder that would prevent participation in a clinical trial such as Tuberculosis or heart failure
* Temporary residents are unlikely to be available for follow up
* Active suicidal ideation or any other severe mental disorder
* Non-residents of Jos and environs
* Unable to consent
* Patients currently undergoing severe mental health treatment
* Unable to speak English language fluently
* Other significant physical or learning disability
Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).

The goal of this pilot study is to determine if intra-arterial (IA) chemotherapy is safe in the treatment of progressive diffuse intrinsic pontine gliomas (DIPG). IA administration of the chemotherapeutic agent enhances the regional distribution of the drug, thereby increasing the local delivered dose while minimizing systemic toxicity. It also provides a treatment option for these patients at the time of tumor recurrence.

Delivering the chemotherapeutic agent directly to the tumor via the arterial system avoids the complications and adverse events associated with toxicity from systemic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients of all ages with progressive DIPG.
* Consensus following presentation of the case at the multidisciplinary Pediatric Neuro-Oncology conference, which includes participation of neuro-oncology, neurosurgery, radiation oncology, interventional neuroradiology and neurology.

Exclusion Criteria:

* Documented hypercoagulable disorders or vasculopathies

  * INR value more than a Grade 1 toxicity by CTCAE v 4.0 criteria (\>1 - 1.5 x ULN; \>1 - 1.5 times above baseline if on anticoagulation).
  * APTT value more than a Grade 1 toxicity by CTCAE v 4.0 criteria (\>ULN - 1.5 x ULN).
* Platelets less than 50 x 103/mm3
* Absolute neutrophil count less than 500/ mm3
* Pregnancy
* Documented severe allergic reaction to IV iodinated contrast, specifically bronchospasm and anaphylaxis.
Effect of Wheelchair Handrail Compensator and Rehabilitation Training for Patients With Hemiplegic Shoulder Pain

The purpose of this study is to determine whether wheelchair handrail compensator plus rehabilitation training could do better than ordinary wheelchair plus rehabilitation training in relieving pain and improving daily life activity, upper limb motor function and quality of life for patients with hemiplegic shoulder pain.

The ideal management of hemiplegic shoulder pain(HSP) is prevention,and a normal limb position is necessary for preventing and reducing hemiplegic shoulder pain.The foam or board supports has been used to prevent shoulder pain and could be recommended for wheelchair users to keep normal position. Therefore, the investigators designed the equipment wheelchair handrail compensator and expected to help paralyzed limbs to maintain a normal position.Using of the wheelchair handrail compensator may help patients achieve: pain relieve, improvement of upper limb function and increase of the quality of life.The aim of this study was to evaluate the effect of treatment by wheelchair handrail compensator and rehabilitation training for people with hemiplegic shoulder pain.

Eligibility Criteria:
Inclusion Criteria:

* Specific diagnosis refer to the "China guideline for cerebrovascular disease prevention and treatment"
* Course of disease range from two weeks to six months
* Age range from 20 to 85 years old
* Brunnstrom scale range from I to II
* Good mental status and could be able to answer questions

Exclusion Criteria:

* Patients with brain trauma, thalamic lesions or peripheral neuropathy
* Patients with a history of cervical spondylosis, periarthritis, fracture or trauma at the shoulder, osteoporosis or myocardial infarction which could cause shoulder pain
* Patients get worse as a result of cerebral edema or coma following stroke
* Patients with serious infection or disorder in heart, liver and kidney
* Patients withdraw from the research by themselves
Accelerometry at the Neck: Comparison With m. Adductor Pollicis Stimulation

Accelerometric Assessment of neuromuscular block during anaesthesia is routinely performed at the M. adductor pollicis. However, many operations require positioning of the patients with arms attached to the body. In these situations, the anaesthesiologist has no access to the m.adductor pollicis.

In this study, a new position of accelerometry at the neck is evaluated: Stimulation of the n. accessorius with accelerometry of the m. trapezius.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anaesthesia with endotracheal intubation
* weight 50-90 kg

Exclusion Criteria:

* Pregnancy
* allergy to one of the drugs used
* risk of pulmonary aspiration
* expected difficulties with endotracheal intubation
* intake of drugs known to influence neuromuscular block
* infection (CRP \> 0,5 mg/dl, leukocyte count \> 12000/µl)
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker

The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.


Eligibility Criteria:
Inclusion Criteria:

* Meet the indications for pacemaker therapy
* Understand the nature of the procedure
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria:

* Meet none of the pacemaker indications
* Meet one or more of the contraindications
* Patients with chronic atrial fibrillation (dual chamber pacemaker only)
* Have a life expectancy of less than six months
* Cardiac surgery in the next six months
* Enrolled in another cardiac clinical investigation
* Have other medical devices that may interact with the implanted pacemaker
the New Biomarker of the Knee Osteoarthritis Knee Osteoarthritis Occurrence and Progression

It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee OA cases were collected from the first affiliated hospital of Shihezi university and healthy controls were recruited from the community. The severity of knee OA was defined as kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The serum concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .


Eligibility Criteria:
Inclusion Criteria:

* OA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons

Exclusion Criteria:

Participants who met the following criteria were excluded：

* the knee OA concomitant with hip OA,
* suppurative and rheumatoid arthritis,
* gout patients,
* patients who underwent knee arthroscopy surgery within 6 months,
* bilateral or unilateral knee replacements,
* the knee joint trauma patients,
* histories of glucocorticoid and/or sterol hormones.
The Application of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU

The goal of this study is to quantitatively assess renal microcirculation changes by contrast-enhanced ultrasound and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore its predictive value in renal function recovery in patients with critical acute kidney injury. The main questions it aims to answer are:

1. To explore the quantitative parameters of contrast-enhanced ultrasound which can reflect the changes of renal microcirculation.
2. To explore the relationship between renal microcirculation and systemic hemodynamics.
3. To explore the value of renal microflow changes quantitatively evaluated by contrast-enhanced ultrasound in predicting renal function recovery.

Quantitative analysis of cortical perfusion by contrast-enhanced ultrasound； Echocardiography； Quantitative results of renal artery and vein spectrum

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old;
* AKI was diagnosed \< 24 hours after first admission to intensive care unit (ICU) and the expected length of stay in ICU ≥48 hours;
* Meet Kidney Disease Improving Global Outcomes (KDIGO) 2012 diagnostic criteria for acute kidney injury;
* Contrast-enhanced ultrasound was performed within 24 hours after diagnosis of acute kidney injury (AKI).

Exclusion Criteria:

* Known severe chronic kidney disease (CKD≥ stage 4) or undergoing hemodialysis treatment;
* Kidney transplantation or renal malignancy;
* Terminal stage of malignant tumor;
* Pregnancy;
* Renal artery stenosis or renal vein thrombosis;
* Allergy to contrast agent SonoVue(BraccoSpA, Milan, Italy) or its components, or the presence of severe cardiopulmonary insufficiency (e.g., right-to-left shunt heart disease or pulmonary systolic blood pressure \>90mmHg).
Alprostadil in Maculopathy Study (AIMS)

Evaluation of efficacy of alprostadil (prostaglandin E1) for treatment of patients suffering from dry age-related macula degeneration

Results of the planned interim analysis indicated that the number of originally planned patients were not sufficient to reach statistical significance in the primary end point. Instead of increasing the sample size accordingly, it was decided to terminate the study and plan future proceedings based on a careful analysis of the unblinded results.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects older than 50 years of age.
* Dry age-related macula degeneration (AMD) with hard drusen and possibly beginning geographic atrophy in one eye
* Visual acuity between 0.2 and 0.7 (logMAR) assessed with ETDRS charts

Exclusion Criteria:

* Dry AMD AREDS category 3 or 4 in both eyes
* Wet AMD in at least one eye
* Detachment of the pigmentary epithelium
* Glaucoma
* Diabetic retinopathy
* Medical history of retinal vein occlusion
* Uveitis
* Cataract surgery during the study
* High myopia (\< -6 dpt) with pathological findings of the retina
* Medical history of any opthalmic surgery with complications
* Medical history of cataract surgery without complications within the last 12 weeks
* Medical history of vitrectomy
* AREDS medication within the last 2 days
* Opthalmologic dietary supplements within the last 2 days
* Medical history of retinal hemorrhage
* Cardiac failure (NYHA grade II or higher)
* Inadequately controlled coronary heart disease or cardiac arrhythmia
* Subject has a medical history and/or suspicion of pulmonary edema or pulmonary infiltration
* Subject has a peripheral edema
* Myocardial infarction within 6 months prior to enrollment
* Subject has renal insufficiency, compensated retention (creatinine \> 1,5 mg/dL)
* Subject has known existing malignant disease
* Severe chronic obstructive pulmonary disease
* Subject has a venoocclusive lung disease
* Known hepatic disease
* Inadequately controlled or untreated hypertension (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg)
* Subject has upper grade cardiac valvular disorders
* Pregnancy or lactation period
* Known hypersensitivity to PGE1 or to any component of the trial medication
* Subject has a history of chronic alcohol or drug abuse within the past 2 years
* Subject has known lactose intolerance
* Poor general state of health or other criteria
* Subject has other serious illness
* Laboratory values outside the normal range unless considered not clinically relevant by the investigator
A First-in-Human, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma

This is a first-in-human, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular domain of human TGF-β receptor II (TGF-βRII).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years.
2. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
3. Histologically or cytologically confirmed advanced solid tumors or lymphoma
4. Measurable or evaluable disease per RECIST v1.1
5. ECOG performance status 0 or 1
6. Life expectancy ≥3 months
7. Adequate hepatic function
8. Calculated creatinine clearance (CrCL) \> 50 mL/min (Cockroft-Gault Equation)
9. Adequate Hematological function
10. Prothrombin time, international normalized ratio or activated partial thromboplastin time \< 1.5 × ULN
11. Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy

Exclusion Criteria:

1. Prior therapy with anti PD-L1/TGFβRⅡ targeting treatment.
2. Symptomatic primary central nervous system (CNS) tumor of CNS metastases.
3. Uncontrolled hypertension.
4. Significant thrombotic or hemorrhagic events.
5. Prior CAR-T therapy
6. Severe cardiovascular disease.
7. Active infection requiring therapy
8. Active HIV, hepatitis B or hepatitis C virus
9. Active tuberculosis
10. Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry
11. Pregnant or breast-feeding females
12. Active or history of autoimmune disease or inflammatory disorders
Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

The goal of the study is to reduce tinnitus (ringing in the ear) loudness and improve the quality of life for those that are affected by tinnitus. This study will enroll subjects who have constant and bothersome tinnitus with no greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss in the tinnitus frequencies. Subjects must also have the ability to alter the loudness or pitch of the ringing in their ears by performing a head, neck, face, or upper body movement. Subjects will be given both the treatment and sham arms (the study will randomly assign which arm is administered first) and will have a washout period of 6 weeks after each arm. The study will take approximately 36 weeks for subjects to complete and will enroll up to 300 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Must report constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
* No greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss at the tinnitus frequencies.
* Must be able to modulate their tinnitus with a somatic maneuver
* Preferably onset of tinnitus less than one year ago, but present for at least 6 months. Tinnitus should be bothersome.
* Absence of retrocochlear pathology/8th nerve lesion
* No participation in a tinnitus treatment regimen within the past six months or participation in the University of Michigan stage 1 clinical trial.

Exclusion Criteria:

* Diagnosis of Meniere's disease
* Diagnosis of Semicircular Canal Dehiscence
* Unilateral or bilateral cochlear implant recipients
* Diagnosis of acoustic neuroma
* Evidence of retrocochlear disease
* Certain medications and conditions (will be reviewed at screening)
Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection

To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection.

To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection by reviewing the medical records of patients who underwent retroperitoneal lymph node dissection for stage I or II gynecological cancer in Far Eastern Memorial Hospital, January 2011\~December 2017.

Eligibility Criteria:
Inclusion Criteria:

* Stage I or stage II gynecologic cancer (including cervical cancer, endometrial cancer, ovarian cancer, and fallopian tube cancer)
* Underwent laparotomic gynecologic oncologic surgery, including retroperitoneal lymphadenectomy.

Exclusion Criteria:

* nil
Study of the Effect of Moxonidine and Diet on Sympathetic Functions in Young Adults With Obesity

The prevalence of obesity is increasing rapidly among adults and has more than doubled in the past 10 years. The metabolic syndrome (MS) is often associated with obesity. It is characterized by abdominal obesity, high blood pressure, unfavorable blood cholesterol profile, elevated blood sugar and impaired insulin action. Persons with the MS have an increased risk of developing type 2 diabetes as well as heart and kidney disease.

The prevalence of obesity and MS is also very high in children and young adults. While there are increasing numbers of studies assessing risk factors for cardiovascular and kidney disease in middle aged to older obese subjects, few studies have addressed the issue of the presence of obesity in young adults and its association with MS on early damage to the organs such as the kidneys, the heart and the blood vessels. The investigators' laboratory has a particular interest on the sympathetic nervous system, which is an important regulatory mechanism of both metabolic and cardiovascular function, as altered sympathetic activity may play a role in the complications of obesity.

Moxonidine is a medication that is approved in Australia by the Therapeutic Goods Administration to treat high blood pressure. It works by decreasing the activity of the sympathetic nervous system. With the elevation of the sympathetic activity in obesity, the investigators believe moxonidine may have a favourable role in rescuing early organ damage associated with obesity. This study will assess whether treating obese subjects with moxonidine have positive effects on blood vessels, cardiac and kidney function and anxiety disorder. The investigators will also examine the influence of the sympathetic nervous system activity in these possible altered cardiac, kidney and vessel functions.


Eligibility Criteria:
Inclusion Criteria:

* Males age between 18 to 30 years old
* Abdominal obesity according to International Diabetes Federation (IDF) definition

Exclusion Criteria:

* Any medications
* history of cardiovascular disease
* history of diabetes
* history of psychiatric illness