cyrilzakka/clinical-trials huggingface dataset:
Study of [14C]CS0159 in China Healthy Subjects

Study of \[14C\]CS0159 in China Healthy Subjects.

A phase I study to quantify the total mass balance in healthy subjects after a single dose of \[14C\]CS0159.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 45 years (inclusive).
2. Subjects should not weigh less than 50 kg, BMI between 19\~26 kg/㎡.
3. No sperm donation or fertility plan during the study and within 12 months after the end of the study.
4. Understand the purpose and requirements of trial, subjects who have voluntarily participated in the study and signed the ICF, completion of tests as required.

Exclusion Criteria:

1. With abnormal and clinically significant comprehensive physical examinations, vital signs,laboratory examinations, 12-ECG, chest X-ray, and abdominal ultrasound.
2. 12-ECG QT(QTcF)\>450ms.
3. The history of drug allergy.
4. Patients with malabsorption and gastrointestinal disorders or history of Vomiting, diarrhoea in the week prior to the screening period.
5. Patients with difficulty swallowing or interfere with drug absorption.
6. HBs Ag or E antigen, TPAb, or HIV-Ag/Ab positive person.
7. Have taken any clinical trial medication or participated in any other clinical trial within 3 months prior to the screening period.
8. Habitual constipation or diarrhoea.
9. Heavy smokers addicts
10. Heavy drinker addicts.
11. Has drug abuse history or positive drug abuse test results.
12. Heavy caffeine addicts.
13. Special dietary requirements.
14. Poor adherence or any other conditions judged by the investigator as not suitable for the study.
A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®

The purpose of this trial is to prospectively assess the relationship between changes in hemoglobin (hgb) and changes in symptom burden associated with anemia in cancer patients receiving chemotherapy supported with Aranesp®.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with nonmyeloid malignancy(ies)
* Anemia (hgb less than or equal to 11.0 g/dL) due to cancer and chemotherapy

Exclusion Criteria:

* Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS)
* Unstable cardiac disease or anemia due to other causes
Study Evaluating the Long-Term Safety of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

The purpose of the study is to learn if long-term treatment with DVS SR is safe for treating the pain and other symptoms associated with diabetic peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients who have completed double-blind treatment in study 322 (NCT01050218) for DPN. Subjects must have completed all scheduled evaluations, with no major protocol violations and no events that, in the opinion of the investigator, would preclude the subject's entry into the long-term open-label study.
* Women of childbearing potential must have a negative serum pregnancy test on day 91 of the short-term study. A woman of childbearing potential is one who is biologically capable of becoming pregnant. "Biologically capable" includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Sexually active women participating in the study who are biologically capable of becoming pregnant must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article. Medically acceptable forms of contraception include oral contraceptives, transdermal, injectable, or implantable methods, intrauterine devices, or properly used double-barrier contraception, eg, condom plus diaphragm.

Exclusion Criteria:

* Presence of any new and/or clinically important medical condition that might compromise subject safety (including, but not limited to, significant changes in glycemic control).
* Pregnancy, lactation, or plans to become pregnant during the study.
* Use of prohibited treatments.
* Meets any of the exclusion criteria listed for study 322 (NCT01050218).
Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis

This study evaluates the effectiveness of N-acetyl cysteine (NAC) in the treatment of progressive multiple sclerosis. Half of the patients will receive NAC, while the other half will receive a placebo.


Eligibility Criteria:
Inclusion Criteria:

* - 40-70 (inclusive) years in age,
* meet 2017 McDonald criteria (Thompson 2018),
* patients with primary or secondary progressive MS (Thompson 2018),
* at least 2 years since progressive symptom onset,
* evidence of clinical changes over the previous 2 years unrelated to relapses: increased EDSS or 20% slowing on 25-foot walk, change of ambulatory support, cognitive change documented on cognitive testing. Progression defined by patients in terms of ambulation perimeter or type of support to ambulate are acceptable if aforementioned physician-based measure changes are not available.
* EDSS score 3.0 to 7.0 (inclusive),
* can be on a stable disease-modifying treatment initiated \> 3 months prior to screening,
* can be on stable doses of dalfampridine initiated at least one month before screening.

Exclusion Criteria:

* - MS relapses in the previous 6 months
* oral glucocorticosteroid treatment within the prior 3 months
* patient with issues undergoing MRI scans
* pregnancy or breastfeeding
* women of child-bearing potential not able to utilize an effective form of contraception for the duration of the study
* history of bleeding disorders
* active gastrointestinal ulcers
* abnormal liver function testing (aminotransferase (AST) or alanine aminotransferase (ALT) \>2 times upper limit of normal)
* current treatment for active malignancy or metastatic malignancy treated in the past year
* alcohol or substance use disorder
* allergy to NAC
* planned surgery or move within 15 months
* use of medications/supplements with antioxidant properties (including over-the-counter NAC)
Ropustin for Refractory Aplastic Anaemia After Radiotherapy - a Single-centre, Prospective, Open-label, Single-arm Study

To investigate the efficacy and safety of roprostin in the treatment of refractory AA after radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years, male or female.
2. Diagnosis consistent with refractory AA after radiotherapy. refractory is defined as patients who have failed to respond to at least an adequate amount of supportive therapy, cyclosporine or povidone TPO-RA for 3 months .
3. At least one of the following conditions was met at enrolment: haemoglobin \<90 g/L. Platelets \<30 x 10\^9/L, neutrophils \<1.0 x 10\^9/L.
4. Baseline liver and renal function is less than two times the normal value.
5. No active infection.
6. Agreed to sign the consent form.
7. Eastern Cooperative Oncology Group (ECOG) score of 0-2.

Exclusion Criteria:

1. Other causes of whole blood cytopenia, such as myelodysplastic syndromes (MDS).
2. Presence of cytogenetic evidence of clonal haematological bone marrow disorders (MDS, AML).
3. PNH clones ≥50%.
4. Hematopoietic stem cell transplantation (HSCT) prior to enrolment.
5. Prior treatment with ATG.
6. Infection or bleeding uncontrolled by standard therapy.
7. Allergy to roprostin.
8. Active HIV, HCV or HBV infection or cirrhosis or portal hypertension.
9. Any concomitant malignancy, localised basal cell carcinoma of the skin within 5 years.
10. Previous history of thromboembolic events, heart attack or stroke (including antiphospholipid antibody syndrome) and current use of anticoagulants.
11. Pregnant or lactating (breastfeeding) women.
12. Participation in another clinical trial within 3 months.
Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care of utilizing existing technologies that are currently more common in food allergy research treatment and clinics (i.e. television and patients' personal electronic devices) for decreasing levels anxiety and fear in pediatric patients undergoing oral food challenge (OFC) and their caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 5 and 17
* Willing to participate in both the VR and standard of care technology conditions
* Able to consent or have parental consent
* Undergoing at least two Oral Food Challenges within the window of recruitment at the Sean N. Parker Center

Exclusion Criteria:

* People who do not consent
* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Current Nausea
* Seizures
* Visual Problems
* Non-English Speaking
* Patients who clinically unstable or requires urgent/emergent intervention
* ASA class 4 or higher
Clinical Trial to Evaluate the Safety and Efficacy of AGR Tablet as a Treatment of Perennial Allergic Rhinitis in Korean

The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean patients with AGR tablet.


Eligibility Criteria:
Inclusion Criteria

* Males or Females no younger than 12 years.
* Patient with a history of perennial allergic rhinitis for at least an year.
* Patient with a positive prick test performed on the same day or within one year before the inclusion date.Patients had to have a (+) prick test for some allergen responsible for non-seasonal rhinitis.
* Patients with a total symptom score before the study of 5 or greater for nasal symptoms only, assessed during inclusion visit.
* Patients able to attend the required number of visits.
* A normal ECG.

Exclusion Criteria

* Patients with non-allergic rhinitis.
* Patients with obstructive nasal polyps or significant deviation of nasal septum in the investigator's criterion.
* Known hypersensitivity to tested drugs(or similar structure) or any components of the tested drugs.
* Asthmatic patients who had experienced an acute clinical attack in the three months previous to the inclusion or who had received or were receiving any type of drug for its prevention or treatment.
* Patients receiving desensitization treatment for any perennial allergen at the inclusion time. However, inclusion of subject stopping this treatment during the study period was permitted.
* Failure to pass properly the washout period of the following period.
Physiotherapy for Chronic Metatarsalgia

The pilot study was conducted in the form of an open prospective single-arm observational study with 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich.

The pilot study was conducted in the form of an open prospective single-arm observational study. The data of 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich was evaluated. The endpoints of Visual Analog Scale Foot and Ankle (VAS FA), Activity Index (AI), plantar and inter-metatarsal pres-sure pain, rearfoot angle and dorsal extension capability of the upper ankle joint were individually compared and analyzed before and after therapy.

Eligibility Criteria:
Inclusion Criteria:

* main diagnosis: Metatarsalgia
* secondary diagnosis: Hallux rigidus,Hallux valgus, Knick-Senk-Spreizfuß, Hohlfuß
* age 30-75 Jahre, gender both
* chronic ( ≥ 3 month),
* pain ≥ 1 visuell analog scale (VAS)
* no other complementary therapy

Exclusion Criteria:

* local: trauma, fracture, tumore, infectionen
* pain after forefoot - operation
* neurological diseases
* generell: somatoform, pension covet
Fluorescent Cholangiography and Bile Duct Stones

Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile duct stones and is the gold standard. There are no studies describing the sensitivity and specificity of IFC for bile duct stone detection.

Research question. What is the sensitivity of IFC to visualize bile duct stones? Method. Prospective study with 40 patients undergoing planned laparoscopic cholecystectomy with preoperative magnetic resonance cholangiopancreatography (MRCP) (gold standard) and intraoperative IFC, X-ray cholangiography and choledochuscopy in that order.

Primary outcome. Sensitivity of visualization of bile duct stone by fluorescent cholangiography and secondary outcome is visualization of anatomy.


Eligibility Criteria:
Inclusion criteria

* Patients suspected of having bile duct stones by either blood samples, MRCP or medical history (see definitions)
* Patient age ≥ 18 years
* Preoperative MRCP
* Operation performed by a project surgeon

Exclusion criteria

* Open cholecystectomy (including conversion from laparoscopic to open)
* Acute cholecytitis or cholangitis
* Pancreatitis
* Iodine or indocyanine green allergy
* Liver or renal insufficiency
* Thyrotoxicosis
* Cholecystectomy not the primary surgical procedure
* Pregnancy or lactation
* Legally incompetent for any reason
* Withdrawal of inclusion consent at any time
Effect of Shockwaves on Fallopian Tubes Adhesion

The purpose of this study is to determine the effect of shock waves on fallopian tube adhesions.

Tubal factor infertility accounts for approximately 40% of the cases of female infertility. Identifiable causes of tubal infertility are post-infectious tubal damage, endometriosis-related adhesions, and postsurgical adhesion formation.

Although surgical management is considered as a common choice for treating blocked tubes or adhesion it has many complications such as: infection, creation of more scar tissue, damage to organs and bleeding.

Shock waves is a modality that exerts an anti-inflammatory action and regenerative effect as well biological model. Shock waves can be nowadays considered an effective, safe, versatile, repeatable, noninvasive therapy for the treatment of many musculo-skeletal diseases, and for some pathological conditions where regenerative effects are desirable, especially when some other noninvasive/conservative therapies have failed.

For these reasons and complications of surgery, This study aims to examine the effect of shockwaves therapy on fallopian tubes adhesion

Eligibility Criteria:
Inclusion Criteria:

* Their ages will be ranged from 25 to 35 years old.
* Their body mass index (BMI) will be less than 35kg/m².
* All women will be diagnosed with fallopian tubes adhesion by the physician.
* They have regular menstrual cycles.
* All Patients have secondary infertility and they have previous caesarean section).

Exclusion Criteria:

* Any gynecological diseases (uterine prolapse, retroversion flexion of the uterus or chronic pelvic pain).
* Leukemia or tumor (spinal or pelvic tumor).
* Diabetes mellitus, hypertension, heart diseases, cardiovascular diseases and skin diseases.
The Bochum Optimizing Clopidogrel-Aspirin Therapy and MORTality Study (BOCLA-Mort)

Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.

The study is aimed to evaluate if optimized antiplatelet treatment using a test and treat algorithm (with whole blood aggregometry) is able to improve clinical outcome of patients compared to standard treatment without platelet function testing.

Eligibility Criteria:
Inclusion Criteria:

* coronary stent implantation

Exclusion Criteria:

* no consent
Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)

The specific aim of this research is to determine if the blood from brain-injured patients contains reproducible protein markers that appear prior to elevations in intracranial pressure (ICP).

One of the major causes of death following brain trauma is increased intracranial pressure (ICP). Currently, there are no effective ways to predict if the ICP of a patient will reach uncontrollable levels. Various cytokines (balance between pro-and anti-inflammatory) and other factors are thought to underlie increases in ICP. The specific aim of this research is to determine if the blood from brain-injured patients contains reproducible protein markers that appear prior to elevations in ICP. We propose to employ mass spectrometry, antibody array and ELISA to profile proteins in the serum of patients suffering from traumatic brain injury. These protein profiles will be compiled by a pattern recognition program that has the capacity to learn and make predictions based on the spectra and associated patient information. Each time a sample is analyzed, it is added to the database allowing the program to make increasingly accurate predictions. Protein profiles of patients with known ICP values will be analyzed. Our hypothesis is that alterations in serum protein composition will precede changes in intracranial pressure giving rise to predictable patterns that can be detected using large-scale proteomic analysis. After approximately 90 non-brain trauma and 90 brain-trauma patients are analyzed, if markers are found, the predictability of elevated ICP will be tested. If successful, this may aid the neurosurgeon in determining future courses of treatment.

Eligibility Criteria:
Inclusion Criteria:

* 14-65 years old
* Non-penetrating brain injury
* ICP monitor or
* Healthy volunteer or

The orthopedic injury cohort will include patients admitted to the ED able to provide informed consent with the following:

1. Fracture confirmed radiographically
2. No head trauma
3. No other known inflammatory process or infection
4. No history of neurological or psychiatric disorders or alcohol or drug dependency.

or The mild TBI patients will be defined as those experiencing,

1. Non-penetrating head trauma manifesting one or more of the following:

   * Loss of consciousness
   * Post-traumatic amnesia
   * Altered mental status
   * Focal neurologic deficits, seizure
2. GCS\> 12
3. No abnormalities on CT other than contusion
4. No operative Lesions
5. Length of hospital stay \< 48 hrs
6. No other known inflammatory process or infection
7. No history of neurological or psychiatric disorders or alcohol or drug dependency

Exclusion Criteria:

* Inability to obtain informed consent
Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects

Investigators analyze the anesthesia of the endolaryngeal laser surgery in patients with smoking with or without monitoring of depth of anesthesia (bispectral index)

All participants are informed about the investigation and are signed the Informed Consent before anesthesia. The study takes place at the Department of Otorhinolaryngology, University of Pecs, Hungary. Between June 2021 and May 2022 ASA I or II patients aged 18-65 years, scheduled for elective endolaryngeal laser surgery with TCI (target-controlled infusion, propofol). Exclusion criteria are epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease. Participants are randomized to two anesthetic groups, anesthesia with or without bispectral index monitoring.

Eligibility Criteria:
Inclusion Criteria:

* endolaryngeal laser surgery with target-controlled anesthesia

Exclusion Criteria:

* epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease
Challenging the Gold Standard: Pilot Study Comparing Continuous Glucose Monitoring System (CGMS), Capillary Glucose Monitors and 3 Hour Glucose Tolerance Test (GTT) to Diagnose Gestational Diabetes Mellitus (GDM)

The purpose of this research study is to compare 3 methods of measuring blood glucose (blood sugar) levels to see if the finger-stick method or the continuous glucose monitoring system is better than or as good as the 3 hour glucose tolerance test (GTT) for the diagnosis of gestational diabetes.

The rate of gestational diabetes and fetal macrosomia is increasing. Moreover, it appears that many macrosomic infants are born to non-diabetic mothers. However, this presents the question of whether our current accepted means of diagnosis is reflecting the true prevalence of GDM. The 3-hour GTT measures glycemic control over a limited period of time. A more prolonged period of monitoring makes more physiologic sense, as it would paint a picture of a patient's overall trend before a diagnosis can be confirmed or excluded. Given the ability of the CGMS and capillary glucose monitor to follow glycemic trends over an extended time period, these methods may prove more effective at identifying patients with abnormal glucose tolerance. As these modalities test the patients in their native environments, the effect of dietary changes prior to the testing period may be minimized, potentially providing an more accurate assessment of abnormal glucose utilization. Furthermore, both modalities should be more cost-effective than the 3- hour GTT.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients seen in the Center for Women's Health at University Hospital in Cincinnati, Ohio between 24-28 weeks gestation
* One hour 50-g Glucose Challenge Test (GCT) value greater than 130 mg/dL.

Exclusion Criteria:

* Patients with known diabetes mellitus
* Patients receiving steroids or oral terbutaline therapy
* Patients entering prenatal care later than 20 weeks gestation
Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product

This study is a multi-center, randomized clinical validation. Subjects should be fully informed of this protocol and related risks, and can only be enrolled into this study after signing the informed consent form. Blood collection of the subjects at the same puncture point at a single site will be injected into the test vial and the control vial respectively, and the vials will be transferred to the BACTEC system for culture and the results will be observed. After the BACTEC system incubation completion, the vials will be subcultured. Strains grown on plates will be identified using appropriate methods and, if possible, at the species level.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to provide written informed consent to sponsor.
* Blood specimens
* Patients with suspected blood infection that have one or more of the following characteristics :

  a) Body temperature \> 38°C or body temperature \<36°C; b) chills; c) increased peripheral blood leukocyte count (count \> 10.0×109/L, especially if there is a "left shift") or decrease (count \< 3.0×109/L); d) Respiratory rate \> 20 beats/min or arterial partial pressure of carbon dioxide (PaCO2) \<32mmHg; e) Heart rate\> 90 beats/min; f) mucocutaneous hemorrhage; g) coma; h) Multi-organ dysfunction; i) decreased blood pressure; j) Elevated inflammatory response parameters such as C-reactive protein or hypersensitive C-reactive protein, procalcitonin (PCT), 1,3-β-D-glucan (G test), etc.

Exclusion Criteria:

* Subjects have been enrolled in this study and samples have been collected
* Patients with severe and very severe anemia (last hemoglobin \<60g/L within seven days)
* Females with known pregnancy
Chronic Constipation With Cerebral Palsy

This study was performed to evaluate posture, sleep, physical activity and quality of life in individuals with chronic constipation Cerebral Palsy.

The study included 81 individuals diagnosed with CP, 3-18 years of age and 2 groups with and without constipation according to Rome IV criteria.

General motor impairment levels with "Gross Motor Function Classification System, motor functions with "Gross Motor Function Measurement, functional independence levels Functional Independence Measurement, spasticity Modified Ashworth Scale , posture characteristics Spinal Aligment and Range of Motion Measurement, with stool characteristics Bristol Stool Form Scale the presence and severity of constipation with the Modified Constipation Assessment Scale and Constipation Severity Scale sleep quality with Pediatric Sleep Questionnaire physical activity level Physical Activity Scale and life quality was evaluated with Pediatric Quality of Life Inventory .

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in research
* Being between the ages of 2-18
* Being diagnosed with Cerebral Palsy

Exclusion Criteria:

* • Having undergone surgery involving intestinal health
* Having a chronic infectious bowel disease
* Having a congenital bowel anomaly
* Having received botox treatment in the last six months