cyrilzakka/clinical-trials huggingface dataset:
This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants

This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK and PD after SAD and MAD in healthy adult participants.

The present study is the first administration of ABL301 in humans. This study will evaluate safety and tolerability and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of ABL301, following IV single ascending dose (Part 1 - SAD), and multiple ascending dose (Part 2 - MAD) administrations, in healthy adult participants.

In Part 1 SAD, seven single doses are planned to be administered in an ascending manner: DL1, DL2, DL3, DL4, DL5, DL6 and DL7. Each dose level will comprise 8 participants randomly assigned in an overall 6:2 ratio (ABL301:Placebo), including 1:1 ratio for the first 2 sentinel participants and 5:1 ratio for the remaining participants, to receive a single dose of study drug or placebo, respectively.

In Part 2 MAD, three multiples doses are planned to be administered in an ascending manner: DL1, DL2 and DL3. Each dose level will comprise 10 participants randomly assigned in an overall 8:2 ratio (ABL301:Placebo)

Eligibility Criteria:
Inclusion Criteria:

* The participant is considered by the investigator to be in good health as determined by medical history, clinical laboratory test results (including urinalysis), physical and neurological examination, vital signs, and ECG.
* The participant agrees to comply with all protocol requirements.
* The participant is a healthy male or female 18 to 55 years of age, inclusive.
* The participant has body weight ≥50 kg and a BMI of 19 to 30 kg/m2, inclusive.

Exclusion Criteria:

* The participant has a history of cardiovascular disease (eg, hypertension, arrhythmia, heart failure, long QT syndrome, or other conditions/diseases causing prolongation of the QT/QTcF).
* The participant has a past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT interval syndrome prior to initial dosing.
* The participant has frequent headaches and/or migraine or recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
* The participant has history of malignancy including solid tumors and hematologic malignancies within 5 years prior to the screening visit (except basal cell and squamous cell carcinomas of the skin that had been completely excised and were considered cured).
* The participant has a history of clinically significant drug or food allergies, as determined by the investigator.
* (MAD only) The participant has a current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the C SSRS), or a lifetime suicide attempt.
Comparing Operative, Postoperative and Quality of Life of Patients After Salvage and Radical Cystectomy

To compare operative difficulties, type of urinary diversion, intraoperative \& postoperative complications and quality of life in patients underwent radical cystectomy and those after salvage cystectomy.

Radical cystectomy is the standard treatment for muscle-invasive bladder cancer. However, in well selected patients, bladder preservation with radiotherapy and chemotherapy with maximal transurethral resection of bladder tumor (TURBT) is done. Nowadays, multiple guidelines support the use of bladder sparing therapy (BST) in the form of a trimodal therapy (TMT) as an alternative to primary RC with curative intent for selected, well-informed and compliant patients, who desire to retain their bladder. Patients usually would prefer a BST, as it is considered tolerable due to its minimal invasiveness with genuinely manageable toxicity. However, a significant proportion of patients may eventually need a salvage radical cystectomy (SV-RC) due to non-response to BST or local recurrence. Salvage cystectomy post-trimodality therapy for intravesical recurrence has an intraoperative and early complication rate comparable to primary cystectomy, Salvage cystectomy post-trimodality therapy is associated with a higher risk of overall and major late complications than primary cystectomy, Irradiated tissue presents technical and surgical challenges, as radiation can lead to an overexpression of cytokines which causes uncontrolled matrix proliferation and fibrosis These post-radiation changes lead to fixation of pelvic organs, making blunt dissection more difficult, as well as causing disruption of surgical landmarks and loss of tissue planes Another consequence of irradiated tissue is that healing is impaired and tissue is weakened, leading to the potential for wound breakdown and fistula formation.

Eligibility Criteria:
Inclusion Criteria:

* patients with muscle invasive bladder cancer ≥ cT2N0/xM0 who underwent salvage cystectomy / going for bladder preservation protocol.
* patients with muscle invasive bladder cancer underwent radical cystectomy.

Exclusion Criteria:

* Patients refusing to participate in our study.
* patients with metastatic bladder cancer
Validation of the 1-minute Sit-to-stand Test in Patients With COPD

This is a study to provide an in-depth validation of the 1-minute sit-to-stand test as a measure of exercise capacity in patients with chronic obstructive pulmonary disease (COPD). Patients will perform the 1-minute sit-to-stand test and other validated exercise tests and questionnaires.

Exercise capacity is a strong predictor for mortality, exacerbations and health-related quality of life (HRQL) in patients with chronic obstructive pulmonary disease (COPD). The 1-minute sit-to-stand test (1-min STS test) is a promising exercise capacity test that is simple to conduct and requires few resources.

This study will provide an in-depth validation of the 1-min STS test, specifically evaluating the tests reliability, validity, responsiveness to change and minimal clinically important difference. The study will also assess the predictive properties of the 1-min STS test with regards to detecting exacerbations, as well as identify patterns of physical activity and patient-reported symptoms of exacerbations.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis according to GOLD criteria; post bronchodilator FEV1/FVC\<70%
* Male and female patients ≥40 years of age
* Able to do at least 5 repetitions in the 1-min STS test at baseline assessment
* Written informed consent by the participant

Exclusion Criteria:

* Lower limb joint surgery in the preceding 3 months
* Too unstable medically to perform exercise tests
* Predominant neurological or musculoskeletal limitation to walking
* Cognitive reading impairment and/or difficulties managing the eDiary and step-counter
Serum DCAMKL1 Pre and Post Treatment in Patients With Pancreatic Cancer

The investigators believe DCAMKL-1 is a stem cell tumor marker and is elevated in patients with pancreatic cancer. The investigators would like to analyze its expression pre and post treatment, to gauge the correlation between current pancreatic cancer therapies and the expression of DCAMKL-1

Pancreatic adenocarcinoma has the worst prognosis of any major malignancy with a 3% 5 year survival. Major obstacles in treating pancreatic cancer include extensive local invasion and early metastasis. The incidence of pancreatic adenocarcinoma (PAC) has been increasing steadily. Epithelial-mesenchymal transition (EMT) plays a key role in cancer invasion and metastasis. Recently, a direct link between EMT and the gain of epithelial stem cell properties has been described. We have recently determined that DCAMKL-1, a microtubule-associated kinase expressed in post mitotic neurons, is a putative intestinal stem cell marker. We have also demonstrated that DCAMKL-1, a protein expressed in both normal stem cells and in cancer, likely promotes tumorigenesis through the regulation of pri-let-7a microRNA and c-Myc. We have recently demonstrated evidence that DCAMKL-1 is a marker for pancreatic cancer stem cells in surgical specimens. This study will investigate expression of DCAMKL-1 in pancreatic tissue obtained through EUS-FNA. Furthermore expression of DCAMKL-1 will also be investigated in serum obtained simultaneously.

Eligibility Criteria:
Inclusion Criteria:

* pancreatic cancer

Exclusion Criteria:

* age \< 18, history of other types of cancer
Executive Functions in Elite Athletes

In the study, it was aimed to compare the executive functions of elite athletes who do team sports and individual sports with each other and with individuals who do not do sports.

In the study, it was aimed to compare the executive functions of elite athletes who do team sports and individual sports with each other and with individuals who do not do sports. 60 elite athletes participating in national and international competitions between the ages of 20-30, affiliated to the Republic of Turkey Ministry of Youth and Sports and federations, and 30 individuals who did not do sports for the control group were included in the study group. Of the elite athletes, 30 were included in the team sports group and 30 in the individual sports group. Executive functions Forward and Backward Digit Span Test, Stroop Test, Trail Making Test A and B form (TMT-A, TMT-B) and Tower of London (ToL) Test evaluated with.

Eligibility Criteria:
Inclusion Criteria:

* Be between 20-30 years old
* Have been doing sports for at least 5 years
* Being an elite athlete
* Being actively involved in sports

Exclusion Criteria:

* Having any psychological or neurological disease
Inflammatory and Degenerative Muscle Disease

Correlation between clinical , ultrasonographical, neurophysiological and histopathological findings in muscle diseases of different etiologies.


Eligibility Criteria:
Inclusion Criteria:

1. Muscle diseases of different etiologies.
2. Any age.

Exclusion Criteria:

1. Patient refuse to participate.
2. The anatomy is altered due to severe trauma, tumor , or surgery.
3. Severe deformity preventing examination.
A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme

This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.

This study was to explore the effectiveness and safety of early temozolomide chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. Patients were treated with a standard therapy regimen (Stupp) plus early postsurgical temozolomide.

Eligibility Criteria:
Inclusion Criteria:

Age: 18 years to 70 years; Newly diagnosed Glioblastoma in the supratentorial cerebral hemisphere; Gross total resection or large resection of \>70% in imaging studies; Eastern Cooperative Oncology Group performance status of 0-2; Adequate bone marrow, liver and renal function; Ability of subject to understand character and individual consequences of the clinical trial Written informed consent; anticipating survival ≥7 months.

Exclusion Criteria:

Refusal to participate the study; Current diagnosis or history of malignancies within the 3-year period preceding enrollment; Recurrent or multiple malignant gliomas, including gliomatosis cerebri, or metastatic extracalvarial or subtentorial lesions; Known hypersensitivity or contraindication to temozolomide; Pregnant or lactating females; Malignant tumor other than brain tumor; Contraindicated for MRI examination; Unable to comply with the follow-up studies of this trial; Uncontrolled psychotic disorders or epilepsy.
Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease

To investigate the prevalence and risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control.

The aim of the present study is to identify the prevalence of peri-implant disease in partially edentulous subjects treated with osseointegrated implants, using clinical parameters, as well as to analyse the possible disease association with demographic, behavioural, and biological risk variables.

Eligibility Criteria:
Inclusion Criteria:

* Partially edentulous patients will implant at least one implant and will be restored with implant-supported fixed partial dentures and single crowns.

Exclusion Criteria:

* Jaw radiotherapy treatment before and after implanting. Patients who have bruxism,xerostomia or the adjacent teeth periapical periodontitis.
* Patients who suffered with oral mucosa disease,or aggressive periodontitis or jaw defect.
* Patients who suffered with mental and psychological disease will influence their oral health normal maintenance.
Congrong Runtong Oral Liquid in the Treatment of Functional Constipation (Yang-deficiency Type)

Using a placebo as a control, this study aims to preliminarily evaluate the clinical efficacy of Congrong Runtong oral liquid for the treatment of functional constipation (Yang-deficiency type), explore the optimal dosage of Congrong Runtong oral liquid for functional constipation (Yang-deficiency type) to provide a basis for dosage selection in Phase III clinical trials, and observe the safety of clinical use of Congrong Runtong oral liquid.


Eligibility Criteria:
Inclusion Criteria:

1. Meets the Rome IV diagnostic criteria for functional constipation;
2. Meets the TCM diagnostic criteria for Yang-deficiency type constipation;
3. Aged between 18 and 70 years (inclusive);
4. Has undergone colonoscopy and has been diagnosed with either no abnormalities or non-adenomatous polyps (size not exceeding 0.5 cm, no more than 3) or has undergone polypectomy for more than 1 month and the pathological examination confirms no high-grade intraepithelial neoplasia within 12 months of colonoscopy examination in a tertiary grade A hospital
5. Less than 3 complete spontaneous bowel movements per week during the 2-week run-in period;
6. Voluntarily participates in the trial and signs an informed consent form.

Exclusion Criteria:

1. Patients with constipation caused by organic lesions of the rectum or colon (such as tumors, inflammatory bowel disease, anal fissure, intestinal adhesions, intestinal tuberculosis) leading to intestinal stenosis;
2. Patients with constipation caused by other systemic organic diseases, such as congenital megacolon, neurological disorders (such as autonomic neuropathy, cerebrovascular disease, etc.), mental disorders, metabolic endocrine disorders (such as hypothyroidism, diabetes mellitus with fasting blood glucose \> 8.6mmol/L or with complications), muscular diseases (such as amyloidosis, dermatomyositis), etc.;
3. Patients whose drug-induced constipation cannot be ruled out by the investigators；
4. Patients with alarm signs judged by the investigator and unable to exclude malignant lesions by colonoscopy in the past three months;
5. ALT or AST ≥ 1.5 times the upper limit of the normal value, or Scr \> upper limit of the normal value;
6. Patients allergic to the composition of the ingredients of the Cenruong Runtong oral solution or bisacodyl;
7. Pregnant or breastfeeding women, or women planning to become pregnant;
8. Patients who have participated in other clinical trials in the past 3 months;
9. Other situations judged by the investigator as inappropriate for participation in this trial.
Influence of Clopidogrel on the Pharmacodynamics and Safety of Terbogrel in Healthy Male Subjects

Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100 mg terbogrel bid.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Healthy male subjects
* Age \>= 18 and \<= 45 years
* Broca \>= -20% and \<= +20 %

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of

  * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * any bleeding disorder including prolonged or habitual bleeding
  * other hematologic disease
  * cerebral bleeding (e.g. after car accident)
  * commotio cerebri
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months days prior to administration or during the trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol (\> 60 g/day) abuse
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the reference range of clinical relevance
* History of any familial bleeding disorder
* Thrombocytes \< 150000/µl
Physical Activity to Mitigate PreEclampsia Risk

The purpose of this study is to compare the effects of aerobic (AE), resistance (RE), and combination (AERE) exercise throughout pregnancy on selected maternal and fetal/neonatal physiological variables in women at-risk for preeclampsia. The central hypothesis of this project is that exercise will decrease severity and occurrence of preeclampsia symptoms, thus improving maternal, pregnancy, and birth outcomes.

Aim 1. Determine the influence of different exercise modes during pregnancy at risk of preeclampsia on maternal cardiometabolic health.

Aim 2. Determine the most effective exercise mode in pregnancy at risk of preeclampsia on improving birth and infant health outcomes.

Approximately 5% of pregnancies worldwide and in the United States were complicated by preeclampsia. Women who develop Preeclampsia in Pregnancy go on to develop Cardiovascular issues (Catov and other studies). Further, infants from preeclamptic pregnancies are at increased risk of mortality and co-morbid conditions (hypertension, excessive weight gain, increased BMI). However, preliminary data suggests that exercise will attenuate or prevent the severity and risk of preeclampsia; thus improving health for women and children. The purpose of this study is to compare the effects of aerobic (AE), resistance (RE), and combination (AERE) exercise throughout pregnancy on selected maternal and fetal/neonatal physiological variables in women at-risk for preeclampsia. The investigators hypothesize that following changes will occur:(1) improvements in the measurements of maternal resting heart rate, blood pressure, cardiometabolic risk (CMR) score, placental growth factor (PlGF), preeclampsia severity, onset of preeclampsia of symptoms at each time point (once per visit); and (2) improvements in birth and infant measurements of decreased C-sections, preterm deliveries, hospital stay, birth weight, placental efficiency at birth when exposed to different modes of maternal exercise compared no exercise (usual care) with greatest differences in AERE trained group. Ultimately, our goal is to determine which exercise program is most effective at attenuating or preventing preeclampsia and thus improving health outcomes for mother and child.

Eligibility Criteria:
Inclusion Criteria:

* healthy women, age 18-40 years, \<16 weeks' gestation, with singleton pregnancy; women (BMI:18.5-45.0), sedentary, cleared by their obstetric provider.

Exclusion Criteria:

* pre-existing chronic conditions such as HIV, lupus, etc.; taking medicines that affect fetal development; and/or lack of telephone or email contact information).
Post-market Safety Reassessment of Ulinastatin for Injection

1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc )
2. Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide evidence for improving the recommended medication plan of ulinastatin.
3. Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.

In order to find out the application of ulinastatin in real practice clinic , identify the high risk group for adverse event/adverse drug reaction and calculate the adverse event/adverse drug reaction incidence rate, a large sample size clinical trial has been designed. This trial is an observational study. The investigators would screen several hospitals from different provinces and prospectively collect the main clinical manifestations,treatment, outcome, influence factors about patients using ulinastatin either in general clinical departments or in ICU. This study would be expected to provide evidence for appropriate medication to administration department of health authority.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ulinastatin treated

Exclusion Criteria:

* Not applicable
A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C

This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. The anticipated time on study treatment is up to 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/=18 years of age
* Chronic liver disease consistent with chronic hepatitis C, genotype 1 infection
* Serum HCV RNA quantifiable at screening
* Patients who have not been previously treated with pegylated interferon (IFN), standard IFN, RBV or any direct acting anti-viral agent
* Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score \</=6)
* Negative urine or blood pregnancy test (for women of childbearing potential)

Exclusion Criteria:

* Women with ongoing pregnancy or breast feeding
* Male partners of women who are pregnant
* Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \</=6 months prior to the first dose of study drug
* Any investigational drug \</=6 weeks prior to the first dose of study drug
* History or other evidence of decompensated liver disease
* History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
* Signs or symptoms of hepatocellular carcinoma
* Co-infection with HCV genotypes other than genotype 1
* Co-infection with hepatitis A, hepatitis B, and/or human immunodeficiency virus (HIV)
* Any patient with an increased risk for anemia
* History of severe psychiatric disease
* History of immunologically mediated, chronic pulmonary, or severe cardiac disease
* Current diseases that are not adequately controlled