cyrilzakka/clinical-trials huggingface dataset:
Preoperative Vitamin D for Post-thyroidectomy Hypocalcemia

The purpose of this study is to determine if pre-operative vitamin D supplementation lowers the incidence of post-operative transient or permanent hypoparathyroidism in patients undergoing total thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total thyroidecomty +/- CND
* Adult (age \> or = 18)

Exclusion Criteria:

* Known chronic kidney disease
* Known primary hyper or hypoparathyroidism
* Known hypoalbuminemia
* Concurrent use medications affecting calcium metabolism
* Completion hemithyroidectomy
Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers

The planned study is to determine the safety and pharmacokinetic properties of CPL500036 compound after single and multiple (two weeks) administration in healthy volunteers.

This is to be one-centre, single ascending dose and double-blind multiple ascending dose two part study of CPL500036 compound in healthy volunteers.

PART A is a single dose, open-label part with CPL500036 compound administered with dose escalation between cohorts.

PART B is a multiple, double-blind part with CPL500036 compound administered for 14 days with dose escalation between cohorts. Participants in this part are to be randomized to receive Investigational Medicinal Product (IMP) or placebo in 3:1 ratio.

Safety and pharmacokinetic properties of CPL500036 compound is to be determined following different doses in single oral IMP administration in PART A and different doses of IMP administered orally for two weeks in PART B.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian female or male,
* Age: 18-55 years old, inclusive,
* Body-mass index (BMI): ≥18.5 kg/m\^2 and \<29.9 kg/m\^2,
* Non-smoker and nonuser of tobacco products for at least 3 months before screening,
* Physical examination without any clinically relevant abnormality,
* Laboratory values not clinically significant,
* Volunteer (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception.

Exclusion Criteria:

* Known allergy or hypersensitivity to other drugs similar in structure or class to CPL500036 compound, or to any excipients of the formulation,
* Any known significant current or past acute or chronic disease or condition,
* Participation in other clinical trial within 90 days preceding the screening,
* Blood drawn within 30 days prior to inclusion to the study (more or equal to 300mL),
* Positive results from pregnancy test for female participants,
* Lactation in women participants,
* Hypotension or hypertension in medical history,
* Long QT interval syndrome or is under the treatment with antiarrhythmic drugs,
* Narcotic, alcohol addiction or abuse,
* Participant who adhere to a special diet (e.g. low calories, vegetarian).
Radiosurgery in Treating Patients With Kidney Tumors

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.

OBJECTIVES:

Primary

* To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.

Secondary

* To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.

Serum Blood Marker Objective:

* To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.

After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.)
* Patient is able to give and sign study specific informed consent
* No prior radiation to the treatment field
* Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
* Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor
* Karnofsky status of ≥ 60%
* Signed study-specific informed consent prior to study entry

Exclusion Criteria:

* Any patient not meeting the eligibility criteria.
* Any patient with active connective tissue disease such as lupus, dermatomyositis.
* Any patient with active Crohn's disease or active ulcerative colitis.
* Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.
Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System

This study is a single-center, randomized controlled trial aiming to evaluate the analgesic mechanism of Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture (TENS-WAA) during unsedated colonoscopy using EEG-fNIRS technology to assess neural activity in brain regions associated with pain perception. Sixty patients aged 18-75 years, with stable cardiopulmonary function and a baseline visual analog scale (VAS) pain score \<3, will be enrolled and randomly allocated into the intervention and control groups. The intervention group will receive TENS stimulation based on the Wrist-Ankle Acupuncture theory 10 minutes before the colonoscopy, with a frequency of 2 Hz and adjustable current intensity ranging from 1 to 9 mA. The control group will receive minimal-intensity sham stimulation under identical conditions. All participants will wear EEG-fNIRS devices to monitor neural activity in key pain-related brain areas, including the prefrontal cortex, anterior cingulate cortex, motor cortex, and parietal cortex. Primary outcomes include EEG-fNIRS data, while secondary outcomes are VAS scores at the four colonic bends, colonoscopy duration, and the correlation between EEG-fNIRS signals and pain perception. Statistical analyses will include multivariable linear regression, generalized estimating equations, and mixed-effects models to investigate the analgesic effects and neural mechanisms of TENS-WAA. This study seeks to provide innovative pain management strategies for patients undergoing unsedated colonoscopy and further explore the neuroregulatory potential of TENS-WAA technology.


Eligibility Criteria:
1. Inclusion Criteria:

   * Patients undergoing unsedated colonoscopy are eligible for inclusion in this study.
   * Aged 18 to 75 years.
   * Meeting the requirements for colonoscopy, with good cardiopulmonary function and stable vital signs.
   * A pre-procedural Visual Analog Scale (VAS) pain score of less than 3.
2. Exclusion Criteria:

   * Participants with speech or cognitive impairments.
   * Those with acute anal or rectal stenosis, acute perianal or rectal infections, acute diverticulitis, or active inflammatory bowel disease.
   * Women who are menstruating, pregnant, or breastfeeding.
   * Patients with active tuberculosis, hemophilia, or advanced malignant tumors.
   * Individuals with sensory disturbances, implanted pacemakers or defibrillators, or ankle skin ulcers.
   * Those who have used sedatives or analgesics either long-term or within the past 24 hours.
   * Individuals with any condition that interferes with EEG-fNIRS signal acquisition, such as cranial abnormalities, implanted metal or electronic devices, epilepsy, or neurological disorders.
Exercise in Gulf War Illness (GWI)

The purpose of this study is to determine if submaximal exercise by bicycle stress tests with pulmonary measurement of VO2MAX plus maximal isometric hand grips on 2 consecutive days causes a higher level of "exertional exhaustion" in GWI compared to healthy veterans (HVets).

Subjects sat on upright bicycles for preexercise symptoms, respiratory gases, EKG, and vital sign measurements.

Submaximal exercise began at low resistance with increases every 30 to 60 seconds until 70% predicted heart rate was reached by 5 minutes. Subjects maintained their pace until 25 minutes, then resistance was increased incrementally to increase to 85% predicted heart rate (approximately sufficient to reach anaerobic threshold).

Symptoms, respiratory gases, EKG, and vital signs were measured every 5 minutes, at peak of exercise, and 5 minute intervals after exercise.

The identical exercise protocol was used approximately 24 hr later. Secondary outcomes were assessed by comparisons from before exercise to after the second bicycle exercise stress test.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:

  * Persian Gulf waters and adjacent land areas
  * Other global locations
  * U.S. only
* Status prior to 1990 and 1991:

  * Active duty
  * National Guard
  * Reserves

Exclusion Criteria:

* Current active duty military personnel
* Any one who was not active duty military personnel between August 1, 1990 and July 31, 1991
* HIV/AIDS; pregnancy or lactation; potential hepatitis; drug addiction; chronic inflammatory, infectious, or autoimmune medical illnesses not associated with GWI; incarceration; dementia, other cognitive limitation; or reliance on a care-giver in order to respond to the questionnaires and other study tests.

Amputations of one or both hands and forearms will be permitted but hand grip tests will not be tested
Vitamin D and Arterial Stiffness in Elderly

Investigators will examine arterial stiffness and pulse waveform analysis. Subjects with vitamin D insufficiency will be recruited. A double blind randomized controlled study will examine the effects of standard dose vitamin D3 (800 IU) versus higher dose vitamin D3 (5000 IU)-given on a daily basis.In order to understand mechanisms of action by which vitamin D would improve arterial stiffness investigators will use biomarkers. Oxidative and inflammatory stress will be measured by plasma F2-isoprostanes and Sulforaphane levels.

Cardiovascular disease disproportionately impacts the elderly. Current practice targets vascular disease with aggressive lipid lowering combined with brachial BP regulation, but has only achieved a modest degree of success. There is a need to intervene at a much earlier stage. Increased arterial stiffness is a marker for subclinical vascular disease and a sensitive predictor of ischemic stroke in the elderly. Vitamin D deficiency is linked to an increased risk of vascular disease.

There is an urgent need for well controlled randomized interventional studies in healthy elderly individuals demonstrating that vitamin D levels can improve vascular function in healthy elderly with vitamin D insufficiency. High dose vitamin D (5000 IU) replacement is required to improve systemic inflammation which may contribute to arterial stiffness and vascular aging.

The hypothesis is that daily 5000 IU vitamin D3 will regress or at least prevent progression of arterial stiffness as assessed by the carotid-femoral pulse wave velocity. Furthermore, investigators postulate that this improvement will be linked to improved oxidative and inflammatory status. Investigators will measure plasma measurements of Sulforaphane and plasma F2-isoprostane to assess the anti-oxidative mechanisms by which vitamin D could influence arterial stiffness.

Eligibility Criteria:
Inclusion Criteria:

* Community dwelling adults (Subjects) aged between 65 and 89 years of age
* Subjects should be ambulatory, living at home and capable of self-care
* Subjects should be able to drive an automobile independently and without assistance
* Subjects agree to home visitation by coordinators to assess pill counts or willing to come to TTUHSC for such a visit every 4 weeks ± 3 days
* 25(OH) Vitamin D value \< 30 ng/ml
* Subjects able to read and understand the English language

Exclusion Criteria:

* Subjects unable or unwilling to have follow up for the duration of the study
* Subjects that cannot take a daily Vitamin D supplement or unwilling to have multiple blood draws
* Subjects on peritoneal or hemodialysis or a life expectancy less than 2 years
* Subjects with Sarcoidosis or diseases associated with hypercalcemia
* Subjects with prior cerebrovascular disease or memory problems
* Subjects with prior myocardial infarction or atrial fibrillation or on anticoagulants
* Subjects on medications for memory or cognitive issues or mental health
* Subjects unable to tolerate Sphygamocor and Complior testing protocol
Degenerative Cervical Myelopathy Repository

To create a research repository of patients with known degenerative cervical myelopathy (DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This repository will be used to assess functional and/or biological measures that may allow for improved prediction of symptomatic progression and response to treatment in patients with DCM. In addition, this repository will be used to develop a risk assessment scale to accurately predict functional outcomes following operative management of DCM.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of degenerative cervical myelopathy
* Diagnosis of cervical degenerative disease without myelopathy

Exclusion Criteria:

* None outside or diagnostic requirements and age limits.
Secur-Fit Advanced Outcomes Study

The goal of this study is to evaluate the Secur-Fit Advanced Hip Stem in primary total hip replacement surgery.

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a cementless application in a consecutive series of patients who meet the eligibility criteria.

The primary objective of this study is to evaluate the success rate of cementless primary total hip replacement with the Secur-Fit Advanced Hip Stem. Success will be defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture at 5 years postoperative. It is expected that the success rate of the Secur-Fit Advanced Hip Stem group will be non-inferior to the selected reference rate of 99% at 5 years postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female, skeletally mature and age 21-75 years at time of study device implantation.
* Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease.
* Patient is a candidate for primary total hip arthroplasty.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* Patient has previously undergone open surgical intervention on the operative hip.
* Patient has a prior femoral fracture, with or without deformity, on the operative side.
* Patient has an existing total hip replacement on the contralateral side.
* Patient requires simultaneous bilateral total hip replacement.
* Patient has a Body Mass Index (BMI) \> 45.
* Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
* Patient has a neuromuscular or neurosensory deficiency that would create an unacceptable risk of instability, prosthesis fixation failure or complications in postoperative care, or which limits the ability to evaluate the safety and efficacy of the device.
* Patient has bone stock that is inadequate for support or fixation of the prosthesis, or is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* Patient has a known sensitivity to device materials.
* Patient is a prisoner.
Functional Magnetic Resonance Imaging Study in Schizophrenia Patients and Correlation With Cognitive Impairments

1. Comparison of functional activity at different brain areas related to different cognitive domains e.g. Memory, visuospatial abilities, executive functions, attention, concentration, language, orientation in schizophrenia to healthy subjects.
2. Correlation with resting functional activity at brain areas with clinical deterioration in cognitive functions.

Schizophrenia represents a multifaceted clinical challenge. Patients' outcome is still highly heterogeneous and poor. Cognitive impairment, a central feature of the illness is present in over 80% of patients with schizophrenia, is a main functional disability. Currently available antipsychotics have only limited effects on cognition and side effects may even aggravate some deficits. So far, pharmacological options for cognitive deficits in schizophrenia are unsatisfactory due to either limited efficacy or tolerability concerns. Understanding the quality, quantity of brain changes could cover patterns of potential therapeutic relevance, guiding treatments. Understanding the pathophysiology of impaired cognition in schizophrenia and developing effective treatment for cognitive symptoms are major unmet challenges for contemporary biomedical research. Briefly, deficits in speed of processing have been correlated with a reduced temporal lobe volume and increased ventricular size. Attention impairments were correlated with structural alterations within the frontal and temporal lobes and with widespread reduced volume of subcortical regions . Decreased working memory was correlated with reduced frontal and temporal lobe volumes and cortical thickness while language and memory deficits were correlated with hippocampal volume loss. Impaired visuspatial and memory correlated with hippocampal volume loss. Deficits in reasoning and problem solving, including higher-order executive functions, were also associated with a reduced the dorsolateral prefrontal cortex volume. Among different neuroimaging modalities, functional magnetic resonance imaging (fMRI) predominates in system-level connectomic studies. Particularly, the task-free version-known as resting fMRI-is better tolerated by clinical populations, and circumvents the need for stringent subject compliance. Today, fMRI features are being rigorously examined to identify potential biomarkers for diagnosis and prognosis of different brain disorders

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis according to Diagnostic and statistical manual of mental of mental disorders -5 (DSM-5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID -I)

Exclusion Criteria:

* History of head injury.
* History of intellectual disability or neurological diseases e.g. cerebrovascular stroke, dementia Parkinsonism, etc.
* History of alcohol and/or substance abuse in the previous six months.
* Inability to provide informed consent.
A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB

The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic hepatitis B patients

The 450 patients meeting the entry criteria are divided into 6 groups, the clinical trial procedure is divided into 3 parts, according to the following steps:

Part1 (0-12W):

1. The research objects will be grouped according to the principle of a multicenter, randomized, open, parallel controlled clinical trial, 300 cases of cell therapy groups (100 cases with PEG-IFN treatment, LdT treatment for 100 cases, ETV treatment for 100 cases), 150 cases of control groups (PEG-IFN therapy in 50 cases, LdT therapy for 50 cases, ETV treatment for 50 cases).

   Part2 (12-36W):
2. Cell therapy groups: enter the HBsAg sensitized dendritic cells activated T cells (HBsAg Pulse DCs-T, HPDCs-T) immune therapy combined with interferon (IFN) or nucleoside analogues treatment (NAs), infusion of HPDC-T every 2 weeks for 1 time, total 12 times.
3. Control groups: antiviral therapy used only (IFN or NAs).

   Part3 (36-72W):
4. The observation stage: discontinuation of interferon in the treatment of 48 weeks; NAs cases will continue on treatment with NAs.

HPDCs-T produced procedure:

The first step: 1-7 days Monocytes will be isolated from peripheral blood of patients. The monocytes obtained will be then incubated in fresh serum-free AIM-V medium (Gibco) containing 800U/ml of GM-CSF and 400U/ml of IL-4 (Peprotech) for 5 days. After 5 days of culture in vitro, The DCs induced will be cultured with a commercially available hepatitis B vaccine containing 10 ug of HBsAg (GSK) for 2 days.

The second step: 8-14 days The hepatitis B vaccine sensitized DCs (HPDCs) (from the first step) will be sub-cultured with patient's own PBMCs for 7 days: HBsAg can be efficiently presented to PBMCs by DCs, with producing HBV specific CTLs and HTLs (HPDCs-T).

The third step: 15 days The PBMCs (the second step) containing enough HPDCs-T will be transfused back into the patient.

Eligibility Criteria:
Inclusion Criteria:

serum hepatitis B surface antigen(HBsAg) positive for at least 6 months; HBV DNA loads≥ 104IU/ml(Roche Cobas); Containing the IFN treatment: 2ULN ≤ ALT ≤ 10ULN and TBil ≤ 2ULN; Containing the ETV/LdT treatment: 2ULN ≤ ALT and TBil ≤ 5ULN; All patients have not received antiviral treatment or immunotherapy for the last 6 months.

Exclusion Criteria:

superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus; other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis; ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination; liver cirrhosis; severe bacterial or fungal infections; a history of diabetes or cardiac disease or hypertension or nephrosis; pregnant women.
Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection

Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing relapse and metastasis of early postoperative NSCLC patients. Method: In this multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group, N=72). Peripheral blood CTCs and immune cells were detect on five different time points: after operation、4 chemotherapy cycles were over、12 months after operation、18 months after operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life of postoperative patients; and decreasing the side effect of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage IB-IIB
2. Accept chemotherapy for the first time 6 weeks after operation
3. Age of 18-75 years old
4. Eastern Cooperative Oncology Group-PS≤2
5. N\>1.5×109/L、PLT\> 100 × 109/L、Hb\>100g/dL、Liver and kidney function is normal or elevated ≤ 1.5 times
6. Voluntary participation in the prospective study with signed informed consent

Exclusion Criteria:

1. No pathology-confirmed diagnosis patients
2. Patients with overall survival time\<6 months
3. Patients with Serious diseases like heart、liver、kidney and hematopoietic system at the same time
4. Pregnant or breast feeding patients
5. Patients with uncontrollable mentally disease
6. Patients with diabetes