cyrilzakka/clinical-trials huggingface dataset:
Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury

This is a double-armed, Phase I/II trial aims to compare bone marrow and leukapheresis as sources for purified, autologous CD34+ and CD133+ stem cells (SCs), to be utilized in treatment of patients with chronic complete spinal cord injuries (SCI). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells into the injured spinal cords of patients.

Spinal cord injury (SCI) leads to apoptosis of oligodendrocytes at the injury site resulting in demyelination and neuronal degeneration. This degeneration causes severe functional sensory and motor mutilations that remain an immense challenge to physicians and in which stem cell (SC) transplantation represents a viable alternative. This study is a phase I/II trial aimed at describing a method for treating patients with chronic complete spinal cord injuries (SCI) by utilizing autologous, purified CD34+ and CD133+ stem cells (SCs). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells in treated patients during a 5-year follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from chronic spinal cord injury
* Age of injury ranging from 6-60 months prior to enrollment in this study.
* Ability and willingness to regularly visit Jordan Orthopedic and Spinal Center for post operation follow up.
* Traumatic Injury of spinal cord with complete or partial damage confirmed by MRI.

Exclusion Criteria:

* Injuries less than 6 months old or more than 60 months old
* Non-traumatic injuries (SCI due to inflammation, autoimmune diseases)
* Patients less than 5 or older than 50 years
* Patients suffering from other conditions, including chronic neurological diseases, diabetes mellitus, cardiac/kidney/liver disorders, previous strokes, and previous surgeries unrelated to spinal cord injury.
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma

The primary objective of this study was to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) by central site imaging facility per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.


Eligibility Criteria:
Key Inclusion Criteria:

1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
2. Unresectable locally advanced or metastatic HCC, which must be confirmed by histologically or cytologically. Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma histology confirmed by histologically or cytologically is excluded.
3. Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy and is not amenable to a curative treatment approach
4. Did not receive any systemic treatment before and is unwilling to accept standard of care treatment or not suitable for standard of care treatment as judged by investigators
5. At least 1 measurable lesion as defined by RECIST v1.1
6. European Cancer Oncology Group (ECOG) Performance Status ≤ 1
7. Child-Pugh A classification for liver function assessed within 7 days of first dose of study drugs

Key Exclusion Criteria:

1. Active autoimmune diseases or history of autoimmune diseases that may relapse
2. Any active malignancy ≤ 2 years before the first dose of study drugs except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
3. Uncontrolled diabetes or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia ≤ 14 days before the first dose of study drugs
4. Any known brain or leptomeningeal metastases
5. Concurrent participation in another therapeutic clinical study

NOT: Other protocol defined Inclusion/Exclusion criteria may apply NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Linear Endosonography for the Assessment of Sarcoidosis Stage O

Patients are often referred for E(B)US examination and sampling of enlarged mediastinal and/or hilar lymph nodes that are not visible on a standard chest X-ray but are discovered by accident on CT scan performed outside the context of lung cancer or extrathoracic malignancies. Since CT scan is largely used and E(B)US is a minimally invasive technique, these cases are explored more frequently but so far nothing is known, however, on the prevalence of abnormal findings in EBUS sampling in this particular population and on the clinical implications (mainly therapeutical implications) of E(B)US findings.

The primary aim is to assess the nature and prevalence of abnormal findings in samplings obtained during E(B)US-NA in the non-cancer patient with CT enlarged mediastinal/hilar lymph nodes that are not visible on chest X-ray. As secondary aims, the clinical implications of E(B)US-NA findings will be assessed, in particular the number of cases where a specific treatment is initiated.

Eligibility Criteria:
Inclusion Criteria:

* Patient referred to bronchoscopy for tissue diagnosis of discrete enlarged (≥10mm short axis diameter) mediastinal/hilar lymph nodes on CT scan that can be sampled by E(B)US-NA.

Exclusion Criteria:

* Abnormal chest X-ray showing hilar/mediastinal lymph nodes
* Patients with suspected lung cancer
* Patients with previous malignancy diagnosed and definitely treated less than 5 years previously or, if treated more than five years before but with subsequent evidence of recurrence less than 5 years previously.
* Patient with concomitant (suspected or confirmed) bronchopulmonary infection or treated with antibiotics within the 4 previous weeks
* Patients with a contraindication for bronchoscopy and tissue sampling
Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

The aim of this study is to investigate the safety and efficacy of prostatic artery embolization of patients with recurrent symptoms secondary to locally advanced prostatic cancer including pelvic pain, bleeding or need for permanent urinary catheter who are unfit for or refuse surgical treatment.

This is a prospective study investigating the safety and efficacy of PAE for patients with prostate cancer who suffers from acute urinary retention, severe LUTS and/or recurrent complications such as haematuria.

Our hypothesis is that PAE will eliminate the need for indwelling catheter and improve IPSS and QoL 12 months post-procedure.

1, and 6 months follow-up.

Main outcome Ability to void after removal of indwelling catheter

Secondary outcomes International Prostate Symptom Score (IPSS) Quality of Life (QoL) International Index of Erectile Function (IIEF) Prostate volume Peak void flow (Qmax) Post-void residual (PVR) Classify complications according to Society of Interventional Radiology (SIR) guidelines for reporting Prostate-specific antigen (PSA)

Eligibility Criteria:
Inclusion Criteria:

* Indwelling catheter secondary to locally advanced prostate cancer (PCa) or
* Moderate-severe Obstructive LUTS secondary to PCa
* Unsuitable for or refuse surgery

Exclusion Criteria:

* Bladder dysfunction(and known neurological conditions affecting bladder function)
* Urethral strictures
* Bladder neck contracture
* Known sphincter anomalies
* Big bladder diverticulum or stones
* Kidney insufficiency (eGFR \< 45)
* Coagulation disturbances
* Severe atheromatous or tortuosity of arteries
* Allergy to contrast medium
* Unable to undergo MR imaging
* Bladder malignancy
Microvascular Blood Flow During Passive Heating

Determine whether passive heating intervention effects microvascular blood flow as measured with near-infrared spectroscopy


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 50 years

Exclusion Criteria:

* Diagnosis of peripheral neuropathy
* open wounds on feet
REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia

To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.


Eligibility Criteria:
Inclusion Criteria:

* Documented to have an RT-PCR-based diagnosis of SARS-CoV-2 infection by RT-PCR
* Moderate-to-severe ARDS as defined by the Berlin Criteria: ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of 200 mm Hg or less assessed with a positive end-expiratory pressure (PEEP) of \>5 cm H2O.
* Intubated for less than 120 hours
* Age ≥18 years
* Ability to provide informed consent or duly appointment health care proxy with the authority to provide informed consent.

Exclusion Criteria:

1. In the opinion of the investigator, unlikely to survive for \>48 hours from screening.
2. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.
3. Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV).
4. Females who are pregnant.
5. Patients with active bacteremia at start of therapy enrollment or concurrently active moderate to severe other infectious which in the opinion of the investigator may possibly affect the safety of CK0802 treatment.
6. Patients who have been intubated for more than 120 hours.
7. Known hypersensitivity to DMSO or to porcine or bovine protein.
8. Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of CK0802 treatment.
9. High dose steroids.
10. Receiving an investigational cellular therapy agent.
Precision Optical Guidance for Oral Biopsy

To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.

Primary objective:

-To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System.

Secondary objective:

-To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible.
2. Ability to understand and willingness to sign a written Informed Consent Document (ICD).

Exclusion Criteria:

1. Known allergy to proflavine or acriflavine.
2. Age less than 18 years.
3. Pregnant or nursing females.
4. Adults unable to consent
5. Prisoners and other vulnerable populations
Spine Quantitative Computed Tomography (QCT)

The purpose of this study is to compare healthy children to children who have a chronic illness called Juvenile Idiopathic Arthritis (JIA). JIA is a childhood disease that causes swollen joints that are often stiff and painful. JIA affects about 1 in 1,000 children age 16 and younger.

Children with chronic illnesses are at risk for bone fragility due to inflammation, glucocorticoid therapy, physical activity limitation, malnutrition, and pubertal delay. The impact of low bone mass during childhood may be immediate, resulting in childhood fractures, or delayed, due to suboptimal peak bone mass attainment.

Eligibility Criteria:
Inclusion Criteria:

* for JIA patients: subjects age 5-21 Drawn from Dr. Burnham's prospective cohort study of bone health in 101 children with arthritis.
* for Control patients: subjects age 5-21 Controls will be a 50% male/female

Exclusion Criteria:

* for JIA patients: Subjects with JIA will be excluded if they have conditions or drug exposure unrelated to JIA and known to impact growth or bone health.
* for Control patients: Chronic disease or syndrome known to affect growth or bone health, prematurity (\<37 weeks gestation), or use of any medication known to affect growth.
Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis

The purpose of this study is to investigate the anti-atherosclerotic effect of long-term anti-inflammatory therapy (Inflaminat) in asymptomatic participants with subclinical atherosclerosis of carotid arteries.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 40 to 70 years
* Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1000-2000 mcm)
* Arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm Hg, diastolic blood pressure \<90 mm Hg)
* Absence of chronic diseases demanding permanent drug administration (more than 2 month per year)

Exclusion Criteria:

* Personal history of stroke or transient ischemic attacks
* Chronic diseases demanding drug administration more than during 2 month per year
* Individual intolerance of Inflaminat or appearance of side effects
CBG Normalization After Discontinuation of COC's

In this study, the investigators aim to examine after which duration corticosteroid-binding globulin (CBG) and total cortisol concentrations return to normal after cessation of the combined oral contraceptive pill in healthy women.

Use of exogenous estrogens is known to increase corticosteroid-binding globulin (CBG) levels and thereby total cortisol concentrations measured in serum. When endocrine function are performed to assess hypothalamus-pituitary-adrenal function, total cortisol levels are measured in serum. When women use exogenous oral estrogen, for instance the birth control pill, the current recommendation is to discontinue oral estrogens for at least 6 weeks before the test. This may introduce diagnostic delay and inconvenience for the patient. The duration it takes for CBG concentrations to return to normal, have not been studied in vivo as far as known by the investigators.

The main objective of this prospective observational study is to determine the duration in which CBG and total cortisol concentrations return to normal after cessation of oral estrogen. Secondary objectives are to examine the normalization of other hormone binding proteins and their corresponding hormones (VDBP \& vitamin D; TBG \& T4, T3; SHBG \& testosterone; IGFBP3 \& IGF1).

The study population consists of healthy women aged ≥18 years old, who are planning to stop using combined oral contraceptives (COCs) for at least six weeks. The study consists of 8 weekly blood samples. The first blood sample will be performed one week before cessation of COCs, the second one at the moment of cessation and after cessation the next six weekly blood samples will be taken.

After establishing when values return to normal, doctors have a better idea of how many weeks after stopping COCs, blood results can be properly assessed. If the duration were shorter than six weeks, this would mean less inconvenience for women undergoing dynamic function tests who would have to stop taking their contraceptive pill.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Using oral combined contraceptives of any kind and dosage
* Planning to stop COC use shortly for at least 6 weeks (out of own reasons such as a pregnancy wish or choice for non-hormone based contraceptives)
* COC use for at least 3 consecutive weeks before the discontinuation
* Ability to provide informed consent
* Ability to speak and understand Dutch

Exclusion Criteria:

* Switching to other hormonal contraceptives after taking the COC pill (e.g. progesterone containing contraceptives such as the Mirena IUD, contraceptive implants) directly after the discontinuations
* Contra-indications to quit COC
* Biological factors that affect CBG concentrations, including:

  * Illnesses interfering with CBG levels (severe liver or kidney disease, active malignancy, hyperthyroidism)
  * Use of insulin, systemic exogenous glucocorticoids, mitotane, selective estrogen receptor modulators (SERMs)
  * Pregnancy during study period after discontinuation of COCs
Patient Reported Symptoms in Ovarian Cancer (PRECISION)

This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred \> 6 months after first-line platinum-based chemotherapy (first recurrence). Patients who have completed second-line chemotherapy and are currently in observation or undergoing bevacizumab maintenance treatment will be eligible to participate in the study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma that has recurred \> 6 months after platinum-based chemotherapy
* This must be the first recurrence of the epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma
* Are at least two weeks but no more than 3 months after the completion of second-line cytotoxic chemotherapy
* Are currently under observation or being treated with bevacizumab as a second-line maintenance therapy
* Have a valid email address and access to the internet
* Provide voluntary written informed consent
* Speak and read English fluently

Exclusion Criteria:

* Current participation in a blinded clinical trial for ovarian cancer treatment. (Participation in a trial involving only supportive care medicines and/or growth factors is acceptable)
* Another primary diagnosis of cancer in a different site
Effect of an Infant Formula on Infant Growth, Health and Immune Functions

The specific objectives of this study are to evaluate the effects of bovine milk osteopontin added to infant formula on infant growth, health and immune functions.

Breast-fed infants will be used as a reference group and formula-fed infants will be fed control formula or the same formula supplemented with Osteopontin at a concentration 50% or 100% of that of breast milk. The hypothesis is that supplementation of bovine milk Osteopontin in infant formula will have positive effects on infant growth, health and immune functions.

Eligibility Criteria:
Mothers Inclusion Criteria:

* Healthy, 19-40 years of age
* Plan to exclusively breast-fed or formula-fed

Infants Exclusion Criteria:

* Gestational age \< 37 or \> 42 weeks
* Birth weight \< 2.5kg or \> 4 kg
* Having congenital diseases
* Having birth Asphyxia
* Having birth infections
Nurse-led Reminder Program for Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients

A number of strategies have been evaluated to improve clinical outcomes in diabetics patients, however no studies explored the efficacy of a nurse-led reminder program through email (NRP-e) to improve medication adherence, even if it is fundamental in the management of diabetics. The study aims at evaluating for the first time the efficacy of a nurse-led reminder program through email (NRP-e) to improve medication adherence in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

To be elegible, all subjects had to be diabetics (Diabetes Mellitus, Non-Insulin-Dependent)

* Speaking and reading italian
* Having an active phone number and an email address
* Providing a signed a informed consent

Exclusion Criteria:

* Mental illness
* Hospitalized patients and who refused to partecipate
Oral Sodium Blood Pressure in Normal Weight, Overweight and Obese Volunteers

The primary objective of this study is to analyze the sensitivity of blood pressure to oral salt intake. Matched male and female participants will be selected as normal weight, overweight, and obese.

Participating subjects will have a first visit with blood pressure measurement and a blood sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6 grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 18-45 for adults and 6-8 for children

Exclusion Criteria:

* African ethnicity (known to affect blood pressure sensitivity to salt)
* Chronic condition affecting blood pressure
* Diabetes (known to affect blood pressure sensitivity to salt)
* Hypertension
An Observational Study to Register the Incidence of Breast Cancer and Current Clinical Care Patterns in Kenya

This observational study, conducted by the Kenya Society for Hematology and Oncology, will develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical and pathological characteristics, treatment and clinical outcome will be collected from newly diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry cohort and followed up for a period of not less than five years.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer
* No previous interventional therapy for breast cancer
* Ability to provide written informed consent as per GCP and local regulations

Exclusion Criteria:

* Participation in other clinical study where the diagnosis and treatment protocol is stated prior to enrolment
* Inability to assess and follow up patient outcomes, for example quality of life due to psychiatric illness or WHO/ECOG performance status IV or worse
Simulator Use in Newborn First Care

The aim of this study is to determine the effects of using high-fidelity simulators in newborn first care training on the knowledge, skills, satisfaction and self-confidence of midwifery students.

Hypotheses H01: There will no difference between the students' knowledge skills, satisfaction, and self-confidence of the simulation-based newborn first care training group and the knowledge skills, satisfaction, and self-confidence score of control group.

The study will be carried out in two different groups. The practice will start with meeting the students who apply to the study. After the students are evaluated in terms of eligibility criteria for the research, the students who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Newborn first care training will be given by the responsible investigator, and then one of the groups separated by randomization will perform newborn first care on the second group model using High Reality Simulator. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one.

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research and obtaining written permission,

Exclusion Criteria:

-