cyrilzakka/clinical-trials huggingface dataset:
Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study

In a multi-national population-based cohort, the investigators want to compare the clinical course and clinical outcome of elderly patients (≥70 y/o) compared with younger patients (\< 70 y/o) with acute subdural hematoma treated surgically. An improved understanding of the clinical outcome and the prognostic factors of acute subdural hematomas would allow physicians to make better decisions about treatment options in traumatic ASDH in the elderly population.

Primary endpoint:

In a population based study to evaluate 30-day mortality (perioperative death) in younger versus elderly (≥70 years) patients with ASDH.

Secondary endpoint(s):

1. Describe pattern of care in younger versus the elderly
2. Clinical outcome (Glasgow outcome scale at 6-months (range, 3-12) follow-up in younger versus elderly (≥70 years) patients with ASDH:

   * Good outcome predefined as GOS 4-5
   * Unfavourable outcome predefined as GOS 1-3
3. 30-day morbidity (according to the Ibanez classification) in younger versus elderly (≥70 years) patients with ASDH.
4. To assess the effect of age as an independent prognostic factor in traumatic ASDH for outcome (GOS) in the elderly (≥70 years) using a three-step approach

   1. Match elderly (cases) with younger (controls) patients with respect to

      1. GCS at admission to treating hospital according to severity - mild (GCS 14-15), moderate (GCS 9-13), severe (GCS 3-8)
      2. Midline-shift (with a cut off of \> 10 mm)
      3. Dilated pupil(s) (yes/no)
   2. Using a multivariable approach with all patients including age (continuous model) to identify independent predictors of an unfavourable outcome (GOS 1-3)
   3. Using a multivariable approach including age as a continuous variable within the elderly population (≥70 years) to identify independent predictors of an unfavourable outcome among the oldest (GOS 1-3)

Eligibility Criteria:
Inclusion Criteria:

* Surgically treated ASDH patients

Exclusion Criteria:

* Post-operative ASDH (i.e. inclusion criteria post-traumatic)
* Intracranial surgery within 6 months prior to trauma
* Permanent intracranial device (i.e DBS electode, VP shunt etc.)
Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)

The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep disorders.


Eligibility Criteria:
Main inclusion criteria:

* GERD
* NERD

Main exclusion criteria:

* Criteria as defined in the Summary of Product Characteristics
A Clinical Study to Evaluate Cyclopofol Injection for the Prevention of Postoperative Nausea and Vomiting

This study uses cyclopropofol as a positive control and adopts a large sample, multicenter, randomized, single-blind, positive parallel control test design to explore the clinical application value of cyclopropofol in preventing postoperative nausea and vomiting.

Before the end of the anesthesia maintenance period/operation, it was divided into groups A, B and C according to different drug regimens. The subjects were randomly assigned to one of them in a 1:1:1 ratio to receive cyclopophenol or sevoflurane anesthesia. Each group of subjects should be roughly consistent according to the proportion of each number of PO . After screening the object, the researchers of each testing center are confirmed by the researchers of the center, log in to the random system, fill in the screening information, obtain the random number information, and distribute the corresponding research drugs according to the random number. The number of random shelters is generated through SAS software, which is used as a centralized random grouping system to import the total number of drugs. This study sets up evaluation researchers and drug management researchers. The whole experimental process turned a blind eye to not only the subjects, but also the evaluators. This study has set up evaluation investigators and administrative investigators. Administrative researchers are only involved in the random grouping, dispensing and delivery process. Other processes, including the subject's informed consent, screening, efficacy indicators and safety evaluation, and planned visits, are completed by the evaluation investigators.

Eligibility Criteria:
Inclusion Criteria:

1. At least 2 of the 4 induced risk factors of PONV (risk factors are: history of PONV or motion sickness, habitual non-smoking, women, receiving opioid analgesia).
2. For patients with an estimated duration of anesthesia ≥1h and ≤3h (non-emergency, non-cardiothoracic surgery and non-intracranial surgery), laparoscopic surgery, gastrointestinal surgery, obstetrics and gynecology surgery, tympanoplasty, tonstonectomy, etc., are preferred. The duration of hand anesthesia was defined as the period from the beginning of anesthesia induction to the end of anesthesia maintenance
3. Male or female, age ≥ 18 years old, ASA-PS score I to III.

Exclusion Criteria:

1. There is a history of vestibular nerve disorder or dizziness or nausea and vomiting 24 hours before the operation; or receiving conventional antiemetic treatment.
2. The subjects who need to maintain ventilation after surgery or need to place the nasogastric tube in place for a period of time.
3. The subject who the researcher believes that there are any other factors that are not suitable to participate in the research.
A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D

This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.


Eligibility Criteria:
Inclusion Criteria:

* Male or nonpregnant female age 18 to 65 years
* Female of childbearing potential on appropriate method of contraception and not nursing
* BMI (body mass index) less than or equal to 30 kg/m2
* Subject is in good health
* Willing to limit direct sunlight and apply sunscreen if in the sun more than 1 hour

Exclusion Criteria:

* mental or legal incapacitation
* received bisphosphonate treatment within 3 months of screening
* unable to sit or stand upright for at least 2 hours
Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

The purpose of this study is to see whether hematopoietic stem cell transplant (HSCT) patients can consistently eat a diet rich in prebiotics. This type of diet may be helpful in maintaining diversity in the gastrointestinal (GI) system and therefore potentially decreasing risk of other GI problems.

Maintaining gastrointestinal (GI) microbiome diversity has been shown to improve treatment related mortality in HSCT patients. Interventions to improve GI microbial diversity could be beneficial to this patient population. Diets rich in prebiotics have been shown to increase gut microbial diversity and improve symptoms in other gastrointestinal diseases. Prebiotics are non-digestible carbohydrates that promote growth of commensal organisms in the gut by providing nutrition. Some examples are brown rice, green apples, and tomatoes. Our theory is that consuming a diet rich in prebiotics pre- and during the first 100 days following HSCT will help to reduce acute graft versus host disease (aGVHD) overall, and specifically acute GI GVHD, and clostridium difficile (C.Diff). Participants will be encouraged to eat at least 2 servings of a prebiotic-rich food from time of admission for HSCT through 100 days following HSCT and will be clinically monitored, including for acute GVHD, acute GI GVHD and C.Diff. Stool samples will be collected from all participants about once every 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Agreement to adhere to Lifestyle Considerations(prebiotic diet) throughout study duration
2. Adults (≥18 yrs of age)
3. Able to provide informed consent
4. Are willing/able to incorporate the required foods in their diet
5. Eligible, suitable and planning to undergo a stem cell transplant:

   1. Either allogeneic or autologous
   2. With any conditioning regimen (e.g. both myeloablative and reduced intensity conditioning)
   3. Matched related, matched unrelated, haplo-identical and cord blood transplants will be included.

Exclusion Criteria:

1. Patients undergoing a second allogeneic or autologous transplant or an allogeneic transplant after an autologous transplant.
2. Anticipation of requirement of broad spectrum antibiotics 1 week prior to admission for HSCT (through HSCT)
3. Patients with any prior history of C.Diff infection
Changes of Endothelial Function Before and After DSA in Patients With Diabetes

Endothelial dysfunction is the early step of atherosclerosis. Therefore, the investigators hypothesize that digital subtraction angiography (DSA) can damage endothelial function. In this study, the investigators will select 200 diabetic patients who have a DSA for diabetic foot screening. Also, the investigators will select 100 healthy subjects as controls. The endothelial function will be determined by high resolution ultrasound before and after DSA. The investigators will observe the changes of endothelial function after DSA assay.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetic foot
* Age 40 to 70 years old

Exclusion Criteria:

* Heart failure
* Renal failure
* Acute infection
Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence

To evaluate the outcome of autologous transobturator fascia lata sling for treatment of female stress urinary incontinence at Al-Azhar university hospitals.

Following induction of anesthesia and administration of perioperative antibiotics, the patient is positioned in the dorsal lithotomy position, sterilization and draping will be done. A sterile 16 French Foley catheter is placed to drain the bladder, following this, injectable normal saline is utilized using 10 cc syringe for hydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides.

Through incision in the lower lateral aspect of the thigh, 4 cm above the knee, \~1 cm× \~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side.

About 1cm skin incision is performed at the thigh fold on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration of the fascial strip.

Eligibility Criteria:
Inclusion Criteria:

* Women with genuine stress urinary incontinence.
* Mixed urinary incontinence with predominant stress element.
* Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment.

Exclusion Criteria:

* Mixed incontinence with predominant Urge urinary incontinence.
* Associated local abnormalities that may affect surgery outcomes (e.g. complete procidentia).
* Recent or active urinary tract infection.
* Recent pelvic surgery.
* Neurogenic lower urinary tract dysfunction.
* Previous surgery for stress urinary incontinence.
* Pregnancy
* Less than 12 months post-partum.
* Other gynaecologic pathologies affecting bladder functions ( eg, large fibroids, ovarian cysts)
* Genito-urinary malignancy.
* Current chemo or radiation therapy.
The Psychophysiological Effect of Simulated and Terrestrial Altitude

The aim of this study is to compare the psychophysiological effects of terrestrial altitude with a normobaric, hypoxic situation.

Research has consistently shown that exposure to extreme environments (such as high altitude stays) may affect cognitive function. For logistical reasons and to control the experimental set-ups, most of these examinations are carried out in the laboratory. By testing under such controlled conditions, researchers can remove any co-foundational factors and isolate the cause of stress, thereby better understanding the mechanisms by which impairment can occur. However, when people are exposed to such environments in the "real world" (such as altitude), they often experience a number of other additional stressors at the same time, which can also affect their performance. Surprisingly, however, little attention has been paid to the study of these additional stressors in combination.

Although the oxygen content remains constant at various altitudes (20.93%), the air pressure decreases exponentially as the altitude increases. As a result, the oxygen partial pressure in arterial blood and tissue is reduced (hypoxia), leading to a deterioration in both physical and cognitive performance. Hypoxic conditions also alter the perception of pain, which may be particularly relevant for patients suffering from hypoxic conditions. According to the authors' knowledge, there is limited literature investigating and comparing simulated and real psychophysiological responses.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adults aged 18 to 50 years
* No cardiovascular disease and / or surgery
* no surgery on the cardiovascular system.
* No current injuries and / or pain
* Regular and adequate sleep
* No terrestrial altitude of 1000 m exceeded last month (including flights)
* No form of hypoxia exposed last month

Exclusion Criteria:

* Age over 50 years
* current injuries of any kind and / or pain
* Acute and / or chronic pain conditions Known general diseases (e.g., diabetes mellitus)
* fear of hypoxia
* fear of heights or sensitivity to terrestrial altitude
* Regular use of medicines (also bought by yourself), except for contraceptives
* Cardiovascular diseases or abnormalities
* Anomalies of the blood analysis or ECG
* Psychological disorders
* pregnancy / lactation
Comparative Study of microRNA Changes in Patients With Reactive Lymphoid Hyperplasia and Malignant Lymphoma

The objectives are to:

1. validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.
2. investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.
3. investigate the dysregulation of miRNA panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia.

The objectives are to:

1. validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.
2. investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.
3. investigate the dysregulation of miRNA panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia.

This trial involves tissue samples diagnosed as lymphoma and reactive hyperplasia. The investigators will develop panels of miRNAs that are specific biomarkers of lymphoma, and assist clinical outcomes with these miRNAs.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and above
* Has condition related to lymphoma or reactive lymphoid hyperplasia

Exclusion Criteria:

* Age below 18 years
* Known pregnancy
* lymph tissue cannot be accessed
Phase I Study of HMPL-523+Azacitidine in Elderly Patients With Acute Myeloid Leukemia

This is a Phase I, open-label, non-randomized, multicenter study to evaluate the safety, pharmacokinetics and preliminary efficacy of HMPL-523 in combination with Azacitidine in previously untreated elderly patients with AML who are not eligible for standard induction therapy.

There are two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2).

Dose-escalation stage (stage 1):

The conventional 3+3 design (3 patients per dose cohort, with the potential to add additional 3 patients to the same cohort to further evaluate toxicity) will be applied for dose escalation and maximum tolerated dosage determination. Approximately 12 to 18 dose limited toxicities evaluable patients will be enrolled. A dose of HMPL-523 up to 800mg will be taken orally once daily continuously through a 28-day Cycle of study treatment. Azacitidine will be administered subcutaneously, beginning on Day 1 through Day 7 of each Cycle.

Dose-expansion stage (stage 2):

This phase is to further evaluate the safety, pharmacokinetics and preliminary efficacy of HMPL-523 in combination with Azacitidine in approximately 28 previously untreated elderly patients with AML. Patients will receive HMPL-523 in combination with Azacitidine in a 28-day cycle continuously until disease progression/relapse, death, or intolerable toxicity, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have confirmation of AML by WHO criteria, except for APL (M3)
2. Subject must be ≥ 65 years of old and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors
3. Subject must have received no prior treatment for AML with the exception of hydroxyurea
4. ECOG performance status of 0-1. For dose-expansion stage, ECOG PS of 2 will also be eligible

Exclusion Criteria:

1. Subject has received treatment of hypomethylating agent and/or chemo therapeutic agent for MDS or MPN
2. Subject has known active CNS involvement or extramedullary sarcoma from AML
3. Subject has favorable risk cytogenetics as categorized by the NCCN Guidelines Version 1, 2018 for Acute Myeloid Leukemia, such as inv(16) or t(16;16) or t(8;21) or t(15;17)
4. Subject has a white blood cell count \> 25 × 109/L (Hydroxyurea is permitted to meet this criterion)
5. Subject with serum amylase or lipase \> the ULN
6. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load.
7. Subject who don't have enough liver or renal function
8. Subject with New York Heart Association (NYHA) Class III or greater congestive heart failure
9. Subject received herbal therapy ≤ 1 week prior to initiation of study treatment
10. Subject received prior treatment with any SYK inhibitors (Fostamatinib) or FLT3 inhibitor (Quizartinib) or multi-target inhibitor with SYK or FLT3 inhibition activity (Midostaurin)
Single-Cell Transcriptomics of the Peritoneal Microenvironment of Colorectal PC

Single cell transcriptomics of CRC PC samples

Research methodology

Before inclusion of patients, patients will be screened for the presence of hepatitis B, hepatitis C and HIV to ensure researcher safety. During cytoreductive surgery, a total of five samples of tumoral tissue will be acquired. Three of those samples will be utilized for ScRNASeq analysis, and two samples of a macrometastasis will be snap frozen and cryopreserved.

Single-cell RNA-Sequencing analysis We will comprehensively catalog the stromal cell types in the microenvironment of colorectal cancer peritoneal metastases utilizing single-cell RNA sequencing (scRNAseq) on three samples (one of which should preferably originate from the omentum majus, to encompass milky spots) acquired from surgical waste material of patients undergoing cytoreductive surgery. After sample prelevation, samples will be transported as soon as possible while cooled and submerged in 10% PBS to the VIB facilities, where single cell suspensions will be made according to standard protocols. After cell selection by FACS (CD45+ and live/dead stain, to ensure a 50/50 mix of immune and stromal cells) and library prep, ScRNASeq will be performed.

Single cell sequencing analysis will allow us to identify cell clusters that by usage of marker genes will be assigned to different known cell lineages. After annotation of data, a "landscape" of the composition of the tumor stroma will be acquired.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing CRS+HIPEC for PC of colorectal origin

Exclusion Criteria:

* Previous HIPEC/PIPAC
A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice

This is a prospective, single country, multi-center study in participants with ulcerative colitis (UC) treated with adalimumab. Up to 147 participants are enrolled at approximately 20 sites. The baseline assessment is performed prior to the first dose of adalimumab (Visit 1). Study visits are conducted at weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. All participants will have one Follow-up for safety approximately 70 days after the last dose of adalimumab.

This is a prospective, single-country, multi-center study in UC patients treated with adalimumab. The prescription of adalimumab is at the discretion of the physician in accordance with clinical practice and label, is made independently from this study, and preceded the decision to offer the patient the opportunity to participate in this study.

Up to 147 subjects are planned to be enrolled at approximately 20 sites. The baseline assessment is performed prior to the first dose of adalimumab (Visit 1). Participants are administered adalimumab 160 mg at Week 0, 80 mg at Week 2, and then 40 mg every other week per the Korean label. Study visits are conducted at Weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. All participants had one Follow-up for safety approximately 70 days after the last dose of adalimumab.

Clinical response is assessed at Week 8, and participants with clinical response at Week 8 can continue on adalimumab treatment as per Korean reimbursement guidelines. Clinical response is defined as a decrease from baseline in the total Mayo score by at least 3 points and at least 30% with an accompanying decrease in rectal bleeding subscore of at least 1 point or absolute rectal bleeding sub-score of 0 or 1.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be an adult ≥19 years
* Participant with active moderate to severe ulcerative colitis with Mayo score of ≥ 6 points and endoscopic sub-score of ≥ 2 points despite treatment with corticosteroids and/or immunosuppressants.
* Participant must have tuberculosis (TB) Screening Assessment in accordance Korean reimbursement guidelines.
* Participants who had started on adalimumab treatment in normal clinical practice setting by their physician.
* Participant must provide written authorization form to use personal and/or health data prior to the entry into the study.

Exclusion Criteria:

* Female participants who are pregnant or breast feeding
* Participant with any contraindication to adalimumab
* Participant that is participating in other clinical trials