cyrilzakka/clinical-trials huggingface dataset:
Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Hydroxychloroquine has been reported to have a clinically significant effect on the platelet count in systemic lupus thrombocytopenia. Its action may be due to its immune modulator effect. Immune thrombocytopenia (ITP) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. However, refractory ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data from this study may provide some idea of Hydroxychloroquine in the treatment of ITP in comparison to other lines of treatment as detected by the standardized definitions.

This study will include patients with chronic ITP attending the out patients clinic of Clinical Hematology Unit of Internal Medicine Department of Assiut university Hospital to evaluate the safety and efficacy of hydroxychloroquine in comparison to other lines of treatment as detected by the standardized definitions . Detect the predictors for chronic ITP especially anti-nuclear antibodies (ANA) role and the effect of the proposed drugs on the level of anti-platelet antibodies. Evaluation of the health-related quality of life after treatments to answer this question; Is the most effective drug is linked to the best quality of life.

Eligibility Criteria:
Inclusion Criteria:

* We will recruit patients with primary chronic ITP patients with ITP lasting for more than 12 months which is proved to be refractory to the standard first line treatment or need to treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding.
* Subject or their guardian has signed and dated a written informed consent.
* Subject experienced no toxicity or known contraindication to any line of treatments.

Exclusion Criteria:

* pregnancy.
* liver and kidney function impairment.
* hepatitis c virus(HCV), human immunodeficiency virus (HIV), hepatitis B virus infection.
* patients with systemic lupus erythematosus and/or antiphospholipid syndrome
* lymphoproliferative disorders.
* an active malignancy
* an arterial or venous thrombosis
* Grade III-IV cardiovascular disease .
* Recent history of alcohol/drug abuse.
* Subjects recently treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for \> 3 consecutive days within 2 weeks of the study start and until the end of the study.
ASSESSMENT OF SURGICAL RISK IN PATIENTS WITH CHRONIC LIVER DISEASE USING VOCAL PENN SCORE

4a. Primary To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score

4b. Secondary To assess potential differences in prediction accuracy between VOCAL-Penn and MELD for 30 and 90-day mortality

For each patient and surgery,we will be collecting detailed pre-operative data regarding demographics (age, sex, body mass index, surgery category, comorbidities (diabetes mellitus, hypertension), and pertinent laboratory values (sodium, creatinine, total bilirubin, the international normalized ratio \[INR\], albumin, platelet count.) The etiology of liver disease will be classified.

To ensure that laboratory data accurately reflected the pre-operative state, only those from within 30 days prior to surgery will be considered For each patient VOCAL PENN score, MELD score, and Mayo score will be calculated using an online calculator.

Eligibility Criteria:
Inclusion Criteria:

* Patients with established cirrhosis Patients who had not received liver transplantation and who underwent surgery of interest were included These surgery categories will be the same as those used in the original VOCAL-Penn derivation study and will include the open abdominal, laparoscopic abdominal, and abdominal wall.

Exclusion Criteria:

* Patients with insufficient pre-operative data to compute the VOCAL-Penn score, Mayo risk score, or MELD-Na score will be excluded.

Patients undergoing liver surgeries Patients who received multiple surgeries Those who didn't give consent
Study of Aripiprazole in the Treatment of Patients With Acute Symptoms of Bipolar Disorder

The purpose of this study is to learn if aripiprazole is effective in the treatment of patients with acute symptoms of Bipolar Disorder.


Eligibility Criteria:
Patients with acute symptoms of Bipolar Disorder
Physical Activity in Postmenopausal Women

The study is designed to investigate the physical activity and its dose-response relationship in postmenopausal women on the cardiovascular risks and cardiac function.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 40 to 80 years and age matched men without major diseases

Exclusion Criteria:

* Known cardiac disease, excessive weight change during last year, cancer and mental disorders
SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)

This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).

This a prospective, single-arm, multicenter study evaluating the efficacy and safety of stereotactic radiotherapy (SBRT) and Zimberelimab(GLS-010) in patients with pancreatic cancer. The primary endpoint is OS, and the secondary are PFS, ORR,DCR and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old.
* Locally advanced pancreatic cancer confirmed histologically and defined according to the NCCN Pancreatic Cancer Guidelines v1.2022 as unresectable or surgically declined.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* The expected survival ≥ 3 months.
* At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
* Patient must have adequate organ function defined by the study-specified laboratory tests.

Exclusion Criteria:

* Tumor invasion of the gastrointestinal tract, specifically pancreatic tumor or lymph node metastasis invading the gastrointestinal parenchyma.
* Woman who are pregnant or breastfeeding.
* Has a known additional malignancy within the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
* Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
* Contraindications to immunotherapy.
* Other conditions that investigator decides not suitable for the trial.
Efficacy and Safety of Sugammadex in Renal Diseased Patients

The purpose of this study is to determine whether sugammadex reverses a profound neuromuscular blockade induced by rocuronium in patients with end-stage renal disease just as effectively and safely as it does in patients with normal renal function.

Sugammadex antagonizes rocuronium induced neuromuscular blockade by encapsulating the molecules of this agent in the plasma and originating a complex which is highly stable, and mainly eliminated by the kidneys. In patients with end stage renal disease, this complex remains in the circulation for days. Previous studies have shown that sugammadex adequately reverses the blockade induced by rocuronium in such patients, and no evidence of recurrence was observed after a dosis of 2 mg/Kg administered to reverse a moderate level of blockade. To our knowledge, nothing has been published so far on the reversal of profound blockade by sugammadex in patients with renal failure.

The aim of our study was to evaluate the efficacy and safety of sugammadex in the reversal of profound neuromuscular block (NMB) induced by rocuronium in patients with end-stage renal failure and compare it to patients with normal renal function.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years old
* end-stage renal disease defined by clearance of creatinine \< 30 ml/min
* normal renal function defined by clearance if creatinine \> 90 ml/min
* candidates to elective surgical procedures (control group) or kidney transplantation (renal group) under general anaesthesia

Exclusion Criteria:

* pregnant and breastfeeding women
* patients with known or suspected neuromuscular disorders
* patients with hepatic disfunction
* a history of malignant hyperthermia
* allergy to narcotics, rocuronium or other medication used during general anaesthesia
* patients receiving medication known to interfere with the action of rocuronium (amino glycoside antibiotics, anticonvulsants, or magnesium)
Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery

This research is for patients who have gastrointestinal cancer and have a planned major surgery. The purpose of this research is to identify cancer patients who may be at risk for frailty. Frailty is common in older adults and may include symptoms of weight loss, weakness, fatigue, low activity, slow walking and other illnesses. Frailty may increase the risk of problems after major surgery. The study will involve a survey, a blood sample, and a review of medical records.

The goals of the study are to:

* Describe the rate of frailty in surgical cancer patients
* Assess if frailty correlates with problems (adverse outcomes) after major surgery

Participants taking part will be asked to complete a survey to assess frailty before surgery. The frailty survey is referred to as the Clinical Risk Analysis Index (RAI-C).

Participants will have about 10 ml (2 teaspoons) of blood drawn before surgery. Blood tests will include complete blood count (CBC), vitamin A, creatinine, C-Reactive Protein (CRP), DHEA, albumin, and prealbumin.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* histologically proven gastrointestinal malignancy
* referral for elective major surgical procedures at including operations for upper and lower gastrointestinal malignancies and hepato-pancreato-biliary
* referral for neoadjuvant treatment followed by any of the above major surgical procedures

Exclusion Criteria:

* under 18 years
* pregnant women
A Study of ARQ 197 in Combination With Erlotinib

This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent for study participation must be obtained
* A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
* History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
* ECOG PS of 0 or 1
* Life expectancy of ≥3 months

Exclusion Criteria:

* Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
* Surgery for cancer within 28 days prior to ARQ 197 dose
* Active double cancer
* Known symptomatic brain metastases
* An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
* Pregnant or lactating
* Subjects who wish to have a child and who would not agree to use contraceptive measures
Standardized Nutritional Management of Pediatric Patients With Solid Tumors

The purpose of this study is to establish a standardized nutrition intervention procedure for children with solid tumors, and to explore the effectiveness and clinical applicability of standardized nutrition management and short peptide-based enteral nutrition intervention for improving the nutritional status of children with malignant solid tumors.

After admission, patients in the intervention group will receive standardized nutrition management provided by a nutrition support team composed of dietitians, nutritionists, clinicians, and nursing teams. Basic information, including diet, enteral and parenteral nutrition, nutritional status and clinical data, will be collected during the study.


Eligibility Criteria:
1. Male and female, age 0-18 years old
2. Pathological diagnosis is malignant solid tumor with untreated initial onset
Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused by plantar fasciitis. Participants will undergo a minimally invasive procedure called plantar fascia embolization (PFE) to reduce inflammation and pain in the affected area. The study aims to assess changes in pain levels, foot function, and any potential side effects over a six-month follow-up period.

This study investigates the use of Lipiodol (ethiodized oil) for plantar fascia embolization (PFE) to treat pain from plantar fasciitis. It focuses on evaluating safety, feasibility, and outcomes related to pain reduction and improved foot function.

Eligibility Criteria:
Inclusion Criteria:Participants aged 22 years or older. Diagnosed with plantar fasciitis by an orthopedic or podiatry surgeon.

Ultrasound evaluation showing:

Increased plantar fascia thickness \> 4 mm. Hyperemia in the plantar fascia near its proximal insertion or perifascial soft tissue.

Self-reported pain of at least 5/10 on the Visual Analog Scale (VAS). Negative X-ray for acute fractures. Refractory to at least 6 weeks of conservative therapies. Able to provide written informed consent. -

Exclusion Criteria:Heel pain caused by stress fractures, nerve entrapment, or inflammatory conditions such as arthritis, gout, or bursitis.

Corticosteroid injection in the plantar fascia within 90 days prior to embolization.

Prior surgical repair or plantar fascia rupture. Severe allergy to Lipiodol or iodinated contrast media. Diagnosis of peripheral arterial disease affecting the lower extremities. Active workers' compensation claim for plantar fasciitis. Pregnancy or breastfeeding. Type 1 Diabetes Mellitus or significant renal dysfunction (GFR \< 45 or serum creatinine \> 2.0 mg/dL).

Sensory or motor neuropathy of the feet. Active skin wounds on the plantar surface of the affected foot.

-
Oral Vaccination Against Clostridium Difficile Infection

This clinical study is conducted to assess the safety and immunogenicity of a Clostridium difficile vaccine (CDVAX) in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Male
3. Age: 18-50 years (limits included)
4. Body mass index within 18.5 and 29.9 kg/m²
5. Ability to read and comprehend study information
6. Non-smokers or light smokers (\<4 cigarettes per day)
7. In good physical and mental health as determined by the following:

   1. Complete medical history
   2. Complete physical and neurological examination
   3. Vital signs including blood pressure, heart rate, respiratory rate, and temperature
   4. Standard 12-lead ECG
   5. Clinical laboratory (biochemistry, haematology and urinalysis) tests. Blood and urine samples may be drawn up to 3 weeks prior to the baseline visit of the study provided all data are available and evaluated prior to administration of study drug. Values of laboratory results outside normal reference ranges may be acceptable if the investigator considers that they do not compromise the safety of the subjects or the conduct of the study.
   6. Vital signs, clinical laboratory measurements, and ECG measurements may be repeated at the discretion of the investigator

Exclusion Criteria:

1. Evidence of C. difficile infection
2. Anti-C. difficile (Toxin A) immunoreactivity, suggesting previous C. difficile exposure
3. Diarrhoea, active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhoea
4. History of malignancy within 5 years
5. History of anaphylaxis, asthma or severe vaccine or allergic drug reaction
6. Known or suspected history of immunodeficiency, active or inactive immune-mediated or inflammatory disease
7. Receipt of antibiotic therapy, immunosuppressants, or corticosteroids within the previous 30 days
8. Vaccination within the previous 30 days (except for influenza vaccination)
9. Blood or organ donation within the previous 60 days
10. Evidence of clinically significant psychiatric, gastrointestinal, neurologic, neuromuscular, hepatic, pulmonary, cardiovascular, or renal disease (as judged by the investigator)
11. Use of prescription medication or regular use of over-the-counter medicines or herbal or dietary supplements. Acetaminophen/paracetamol may be used intermittently as needed for pain
12. History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
13. Positive hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV)-1/2 antibodies
14. Participation in any other investigational drug or device study within 60 days prior to the first study drug administration
15. Relatives of, or staff directly reporting to the principal investigator
16. Vulnerable subjects
NIRS Levels of Infants in Neonatal Intensive Care

Aim: This study was conducted to determine the effect of nursing care practices on the Near Infrared Spectroscopy (NIRS) levels of premature infants in the neonatal intensive care unit (NICU).

Materials and Method: This is a cross-sectional, analytical study. It was conducted over the period March 1 - April 26, 2019 in the Neonatal Intensive Care Unit (NICU) of Eskişehir Osmangazi University (ESOGU) Health Practices and Research Hospital. We did not calculate sample size, but included in the study, after the parents had been informed about the research, the entire universe of neonates in the NICU who matched the inclusion criteria during the period March 1 - April 26, 2019. The study was completed with 40 neonates. Data collection was performed with a "Descriptive Data Form," and a "Procedures Performed Chart." The data were evaluated with the IBM SPSS 24 package program.


Eligibility Criteria:
Inclusion Criteria:

* Neonates younger than a gestational age of 37 weeks
* Those monitored in an open or closed incubator

Exclusion Criteria:

* Intubated neonates connected to a mechanical ventilator
* Infants of a gestational age of 37 weeks or more
* Infants under sedation
* Infants with neurological illness (e.g., hypoxic ischemic encephalopathy, hydrocdphalus)
China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).

The CARE-TCM is a prospective, multi-center, patient registry study. Eligible ALS patients with TCM treatments will be enrolled in the registry. After enrollment, this research collects the individual characteristics of patients' status. Longitudinal follow-up data are collected from both patients (primary caregivers) and their treating neurologists every 3 months for 5 years. The aims of the CARE-TCM are to: 1) explore the general characteristics of ALS patients with TCM and; 2) assess the effectiveness and safety of various TCMs on ALS based on nationwide registry outcome collecting process.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older.
* Patients with possible, laboratory supported probable, probable, or definite ALS according to the revised El Escorial criteria.
* ALS patients treated with traditional Chinese medicine.

Exclusion Criteria:

* Patients who refuse informed consent.
Bone Density in Immediate Implant Placment and Loading(BDIIPL)

Atrumatic extraction ,immediate implant placment , prf as plug,immediate loading , mesure bone density 0-3-6-9 month

Atrumatic extraction unrestorable tooth in esthetic zone and immediate implant placment and withdrow 10cc blood sample to gain prf plug as membrane and immediate provisional for one week and final restoration after 1 week , and mesure bone density from 0-3-6-9 month

Eligibility Criteria:
Inclusion criteria:

* unrestorable anterior tooth.
* Good oral hygine
* Adequate bone hieght apical to the alveolus of failing tooth to ensure primary stability .

Exclusion Criteria:

* systematic disease which affect osteointgration.
* Bad oral hygiene
* Broxism, clenching, deep bite, edge to edge and abnormal habits.
* Non-treated peeiodontal diseases.
* Pregnancy and smokers. Severe infection. Loss of labial crest after extraction of failing tooth.
Determining the Lymphokine Activated Killer (LAK) Cytotoxicity Present in Patients Undergoing Interleukin-2 Therapy

Therapy with Interleukin-2 stimulates lymphocytes in humans to become Lymphokine-activated Killer cells (LAK). This study will determine if these killer cells are able to kill certain standard cell-lines in the laboratory.

Blood samples will be taken from patients undergoing outpatient Interleukin-2 therapy to measure the LAK cytotoxicity at baseline, after 1 cycle of therapy and 2 months later. The LAK cytotoxicity assay will be a standard colorimetric assay that measures lactic dehydrogenase release from lysed cells.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be undergoing Interleukin-2 therapy under the care of physicians at Loma Linda University Cancer Center
* Patients must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

* Patients not undergoing Interleukin-2 therapy under the care of physicians at Loma Linda University Cancer Center
Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods.

Measuring Cardiovascular Performance Using Common Methods in subjects.

This study will conduct measurements of cardiovascular performance by echocardiography (Echo), Brain Natriuretic Peptide (BNP) blood serum levels and blood flow by volume plethysmography (VP) in subjects who meet the AHA/ACC criteria for screening for peripheral arterial disease (PAD).

Eligibility Criteria:
Inclusion Criteria:

* At least 50 Patients from New York Heart Association (NYHA) Class 1 (One or more AHA Risk Factors, asymptomatic), ≤75% (36) Male, ≥25% (12) Female
* At least 50 Patients from NYHA Class 2 (symptomatic), ≤75% (36) Male, ≥25% (12) Female

Exclusion Criteria:

* Subjects on mechanical ventilation.
* Subjects who require decisions by a medical power of attorney.
* Subjects unable to safely perform forced expiration.
* Subjects with known technically difficult (TDS) trans-thoracic echocardiographic windows.