cyrilzakka/clinical-trials huggingface dataset:
Patient Satisfaction With Sedated vs. Unsedated Colonoscopy

This is a prospective, observational study to evaluate patient satisfaction with colonoscopy, depending on whether sedation is used during the procedure or not. Patients will receive questionnaires before the procedure to assess the potential influence of patient criteria and after the procedure to assess satisfaction-scores and pain-scores. A validated satisfaction score (Schoen et al.) will be used for the primary outcome. As secondary parameters, pain- and sedation-scores will be assessed by the validated NAPCOMS score, as well as procedural quality indicators. The study will assess, whether adequate selection in regards to risk factors for sedated or unsedated colonoscopy, leads to similar satisfaction-scores within both groups.

This is a prospective, observational study of consecutive patients presenting for outpatient colonoscopy in a tertiary care hospital with a large ambulatory care section (DKD Helios Klinik Wiesbaden). The primary endpoint of the study is the comparison of a validated patient satisfaction score in patients undergoing colonoscopy with or without sedation. The aim is to assess whether patients, who are deemed appropriate for an unsedated procedure by predefined risk factors and who wish to avoid sedation, will have similar satisfaction scores, as those who undergo sedation. As secondary aims, pain scores (validated NAPCOMS score) and markers of procedural quality (such as completion rates or withdrawal times) will be assessed.

Considering a 2-point difference in the 15-point satisfaction score as clinically relevant and suspecting a 7:3 distribution of procedures with and without sedation, respectively, 1070 patients must be included (at least 749 sedated and 321 unsedated) in order to reach a significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients presenting for colonoscopy
* Age \>18 years

Exclusion Criteria:

* Patients not giving written consent
* Colonic stenosis or suspected Stenosis
* Active inflammatory bowel disease
* Previous partial resection of the colon
* Polyposis syndromes
* Inability to speak German or fill out a questionnaire in German language
* Vulnerable patients (prisoners, pregnant women, patients with mental retardation, which would affect filling out a questionnaire or answering questions)
* American Society of Anesthesiology (ASA) grade \> III.
Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD)

The aim of the study was to evaluate the effect of 7 days treatment with Pantoprazole 40 mg and 20 mg on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) in clinical practice. During the study, the patients had to complete a short version of a patient-orientated, self-assessed reflux questionnaire (ReQuest™ in Practice).


Eligibility Criteria:
Main inclusion criteria:

* Outpatients with erosive gastro-esophageal reflux disease (eGERD according to Los Angeles classification grade A-D) or non-erosive reflux disease (NERD)

Main exclusion criteria:

* Criteria as defined in the Summary of Product Characteristics (Chapter 4.3)
Effectiveness of Evening Primrose Oil for Induction of Labor

Effectivness of primrose oil in induction of labour .

Using primrose oil in addition to misoprostol for induction of labor in one group of pregnant women and compare the result with those of another group in which we are using misoprstol only.

Eligibility Criteria:
Inclusion Criteria:

* pregenent of 38 weeks and longer
* singleton pregenency
* vertex presentation
* indication of labor induction
* bishop score \<6 and cervical dilation\<2 cm

Exclusion Criteria:

* women who delivered by classical cs or had a history of myomectomy , hysterscopic uterine surgery , or cervical surgery like conisation
* women with multiple gestation
* women with evidence of low implanted placenta by ultrasound
* women with contraindication to misoprostol or vaginal delivery
Epigenetic Biomarker for Osteosarcoma

hMe-Seal is a low-input whole-genome cell-free 5hmC sequencing method based on selective chemical labeling. It uses β-glucosyltransferase (βGT) to selectively label 5hmC with a biotin via an azide-modified glucose for pull-down of 5hmC-containing DNA fragments for sequencing. After selectively constructing 5hmC library, highthroughput-sequencing will be performed on an Illumina Nextseq-500 instrument. By ways of Rawdata processing, differential loci between Osteosarcoma group and control group will be detected to indentify specific epigenetic biomarkers of Osteosarcoma.

The investigator want to enroll 100 osteosarcoma participants initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital(PKUPH). All those participants will follow the chemo-protocol for osteosarcoma in PKUPH.8 ml of peripheral blood would be drawed before each cycle of chemotherapy for further analysis. After definitive surgery, participants will need to take 8ml of peripheral blood every 2 months for 6 months. A total of 6 times of blood drawing will need to be done.

In hMe-Seal approach, peripheral blood is collected into EDTA-coated Vacutainers. Plasma is collected from the blood samples after centrifugation at 1 600× g for 10 min at 4 °C and 16 000× g at 10 min at 4 °C. CfDNA is extracted using the Circulating Nucleic Acid Kit(QIAGEN). After that, cfDNA (1-10 ng) is end repaired, 3'-adenylated and ligated to DNA Barcodes using KAPA Hyper Prep Kit (Kapa Biosystems). Ligated DNA is incubated in a solution containing HEPES buffer, UDP-6-N3-Glc and βGT . After that, DBCO-PEG4-biotin is directly added to the reaction mixture. Next, DNA is purified by Micro Bio-Spin 30 Column (Bio-Rad). The purified DNA is incubated with M270 Streptavidin beads (Life Technologies) in specific buffer. The beads are subsequently undergone three 5-min washes each with four kinds of different buffers. All binding and washing are done at room temperature with gentle rotation. Beads are then resuspended in water and amplified with 16 cycles of PCR amplification. The PCR products are purified using AMPure XP beads. Pair-end 38bp sequencing is performed on the NextSeq-500 instrument.

Eligibility Criteria:
Inclusion Criteria:

* 1) histologically confirmed high-grade osteosarcoma;
* 2) older than 10 yrs;
* 3) initially treated in Musculoskeletal Tumor Center of Peking University People's Hospital;
* 4) Serum samples are available;
* 5) completed neo-adjuvant chemotherapy and at least 8 cycles of adjuvant chemotherapy;
* 6) expected to live longer than 3 months with Eastern Cooperative Oncology Group performance status of 0 or 1;
* 7) acceptable hematologic, hepatic, and renal function.

Exclusion Criteria:

* 1) Serum samples are not qualified;
* 2) Patients who could not complete neo-adjuvant chemotherapy or at least 4-month adjuvant chemotherapy;
* 3) lost to follow-up.
A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women

This is a prospective, randomized, double-blind, crossover study. The purpose of this study is to determine whether Farabloc fabric is effective in alleviation of hot flash symptoms in menopausal women. This study will require all prospective participants to fill out a week of Hot Flash Diary to determine eligibility before beginning the study. All prospective participants will be assessed for hot flash frequency, hot flash distress and hot flash severity according to their perception in the Hot Flash Diary during the experimental period.

Fifty menopausal volunteers will be randomly assigned to two groups, one receiving Farabloc fabric containing Farabloc (experimental), and the other a similar-appearing fabric made of Nylon (placebo).

All eligible participants will be selected by the initial interview. The following information will be collected during interview process.

* Address
* Medical history
* Concomitant medication
* Allergies

Participants will be asked the following:

1. On a scale from 1 to 10, how much are you bothered by your hot flashes?
2. Do these hot flashes wake you up at night? Around how many times do they occur at night?
3. What are you expectations about this study?

A Menopause Rating Scale questionnaire will be completed by the potential participant to assess symptoms Eligible patients from each group will initially undergo a 7 day washout period before intervention in order to eliminate any effects of hormone replacement therapies (HRT) or herbal supplements that subjects may be using prior to participation in the study. Subjects will be randomized to receive a Farabloc fabric or placebo fabric for one week. After this, the two groups will undergo a second 7 day washout period before crossing over to the other fabric. Once crossed over, participants will use the allocated fabrics for another week.

Participants will be asked not to take their usual HRT or herbal supplements for the entire experimental duration in this study in order to produce impartial, precise and reliable results.

The manufacturer will assign codes for placebo fabric or experimental Farabloc. The randomization code will be broken at the completion of the study for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Women with 12 months amenorrhea
* Experiencing more than 2 nocturnal hot flashes nightly.

Exclusion Criteria:

* Other medical conditions associated with night sweats
* Currently on medication associated with night sweats
* Less than 2 nocturnal hot flashes per night
* Allergies to metals
* Abnormal mental status
* MRS scale rating of mild or above
* Currently on hormone replacement therapy or herbal supplements and cannot safety discontinue these for the duration of the study.
A Study of LCAR-G08 in Subjects With Advanced Gastrointestinal Tumors Expressing Guanylyl Cyclase C (GCC)

This is a phase 1, single-arm, open-label, dose escalation and expansion study of LCAR-G08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase C (GCC).

This is a phase 1, single-arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR- G08 in subjects with guanylyl cyclase C (GCC)-positive advanced gastrointestinal tumors. Subjects who meet the eligibility criteria will receive LCAR-G08 infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary agreement to provide written informed consent.
* Histologically confirmed metastatic colorectal cancers and other advanced gastrointestinal cancers (esophageal cancer, gastric cancer, pancreatic cancer, and small bowel cancer).
* Aged 18 to 70 years, either sex.
* GCC immunohistochemistry (IHC) staining is positive.
* At least one measurable tumor lesion according to RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Expected survival ≥ 3 months.
* Clinical laboratory values meet screening visit criteria.

Exclusion Criteria:

* Previous CAR-T cell, T cell receptor-engineered (TCR) T cell, or therapeutic tumor vaccination treatment within the past 6 months; and the corresponding CAR-T, TCR-T cells can still be detected.
* Ever received any treatment targeting GCC.
* Prior antitumor therapy with insufficient washout period.
* Brain metastases.
* Pregnant or lactating women.
* Hepatitis C virus (HCV) antibody-positive or human immunodeficiency virus (HIV) antibody-positive, active syphilis, Epstein-Barr virus (EBV) infected.
* Severe underlying disease.
* Presence of other serious pre-existing medical conditions that may limit patient participation in the study.Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.

Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
Metabolic and Prolonged Satiety Effects of a Breakfast Kit

The mobilizing programme MobFood - mobilizing scientific knoweledge and technology to answer the current nutrition market challenges - is formed by a consortium of 47 collaborative entities, between the industry and ENESIIs (Entidades Não Empresariais do Sistema de Investigação e Inovação) and is financed by Structural European Funds of Investment.

The project is currently investigating and undertaking collaborative scientific and technological strategies based on R\&D and innovation, in order to boost and promote a more competitive national food industry, capable of overcoming the current challenges, including those of the Millennial Generation. This group is particularly conscious of the impact of food behaviour and food choices on health but extremely vulnerable to dietary imbalance. Strategies to improve Millenials' nutrition while providing conscious food products are needed.

This study is a randomised, cross-over controlled trial designed to test the metabolic effect, particularly in terms of appetite control and glycaemic response of a breakfast kit (nutritionally balanced and innovative), recently developed as part of the collaborative project MobFood_PPS4.


Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* Born between 1981 and 1996;
* Body mass index (BMI) between 18.5 kg/m2 and 24.9 kg/m2;
* Normoglycemic according to American Diabetes Association criteria \[Fasting Plasma Glucose \< 100 mg/dl, 2-h plasma glucose value during a 75 g oral glucose tolerance test (OGTT) \< 140 mg/dl)\];
* Healthy.

Exclusion Criteria:

* Overweight or obese (BMI ≥ 25,0 kg/m2);
* Recent body weight loss/gain \>10%, within previous 3 months;
* Being on a weight loss/other special diet (e.g. Paleo diet, Atkins diet, flexitarian diet or ketogenic diet), within previous 3 months;
* Clinically significant illness, including:

type 1 or type 2 diabetes; liver disease e.g. cirrhosis; malignancy; pancreatitis or other malabsorption; gastrointestinal disorders e. g. intestinal bowel disorder, celiac disease; previous weight loss surgery e.g. bariatric surgery; chronic respiratory, neurological, psychiatric, musculoskeletal diseases/conditions; diagnosed eating disorders.

* Individuals who don't regularly consume breakfast;
* Having taken antibiotics within the 12 weeks prior to beginning the study;
* Taking other medication that could potentially affect body weight, glucose metabolism and/or appetite (e.g. GLP-1 analogues);
* Being engaged in competitive sports;
* Having \>14 or \>8 (males and females, respectively) alcoholic units/week; misuse of drugs;
* Having donated blood within one month prior to the beginning of the study;
* Nut or milk allergy, or other food allergy or intolerance that would compromise compliance with the study protocol;
* Pregnant or breastfeeding.
MAGNET Ingestion in Children

One year national observational surveillance study of children who ingest a magnetic foreign body

The study aims to understand the incidence, management and outcomes of children who ingest a magnetic foreign body.

Eligibility Criteria:
Inclusion Criteria:

* Magnetic foreign body ingestion
* 16 years of age or less

Exclusion Criteria:

* Non ingested foreign body
Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL

In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed/refractory (R/R）B-ALL. The available data suggest that the advancement of immunotherapy from relapsed/refractory (R/R) field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph- B-ALL patients achieving complete remission (CR) with chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.

The CAR-T cells were murine-derived second-generation CD19 CAR-T with a co-stimulation domain of 4-1BB, and the infusion dose was 1×10\^6/kg CAR+ cells in a single infusion.

Eligibility Criteria:
Inclusion Criteria:

1. De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification
2. Male or female patients aged 18 years or older
3. CD19 expression on blasts
4. Expected survival time greater than 3 months
5. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%
6. Subject has provided written informed consent prior to any screening procedure

Exclusion Criteria:

1. Burkitt lymphoma/leukemia
2. Acute Leukemia of Ambiguous Lineage
3. Clinical manifestations of active CNS or extramedullary involvement with ALL
4. Female patients who are pregnant or breast feeding
5. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
6. Known HIV seropositivity
7. Clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal) or sinus block, history of chronic bradycardia with a high degree of atrioventricular (AV) conduction block (unless a permanent pacemaker is implanted)
8. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
9. Other conditions assessed by the investigators to be inappropriate for this study
Endotoxin & Cytokines. Do Protein Loss and Metabolic Effects Depend on Central Nervous System (CNS) Activation of Stress Hormones or on Local Mechanisms in Muscle and Fat?

Main objective :

The purpose of this study is to prove that the effects of bacterial endotoxin and cytokine TNF-α, on protein loss, fatty acid release, and glucose metabolism depend on two mechanisms:

1. Direct local effects in muscle tissue.
2. Activation of the hypothalamo-pituitary axis and a stress-hormone response

Study protocols:

1. Acute metabolic effects of TNF-α(Beromun, Boehringer-Ingelheim Germany) vs placebo perfused into the femoral artery of the leg in 8 healthy subjects.
2. Acute metabolic effects of

   * placebo(saline)
   * endotoxin(US standard reference E.Coli, endotoxin)
   * TNF-α(Beromun, Boehringer-Ingelheim Germany) given systemically
   * in 8 patients with hypopituitarism(to block stress hormone release) and in 8 healthy subjects all studied thrice.

PURPOSE:

Knowledge about the effects of bacterial endotoxin and cytokines (and inflammation in general) in humans on protein, glucose and lipid metabolism and intracellular signalling in muscle and fat is sporadic and it is uncertain whether endotoxin and cytokines act directly in fat and muscle tissue or indirectly via central nervous system (CNS) mediated stress hormone release.

The investigators hypothesize that the metabolic effects of endotoxin and cytokine TNF-α, including protein loss, fatty acid release and decreased glucose uptake depend on two mechanisms:

1. Direct local effects in muscle tissue (Study protocol 1)
2. Activation of the hypothalamo-pituitary axis and generalized stress hormone response (Study protocol 2)

METHODOLOGY:

Study protocol 1:

Acute metabolic effects of TNF-α (Beromun, Boehringer-Ingelheim, Germany) versus placebo perfused into the femoral artery of the leg in 8 healthy subjects, studied once. Femoral vein sampling allows assessment of local metabolic events in the leg. The vessels were cannulated using the Seldinger technique. Each study comprises a 3 hour basal period and a 3 hour Hyperinsulinemic-Euglycemic Clamp. Muscle biopsies were obtained simultaneously from both lateral vastus muscles.

Study protocol 2:

Acute metabolic effects of (i)placebo (saline), (ii)endotoxin (US standard reference E.Coli, endotoxin) and (iii)TNF-α (Beromun, Boehringer-Ingelheim, Germany) given systemically intravenously (i.v.) in 8 patients with hypopituitarism (to block stress hormone release) and in 8 healthy subjects all studied thrice. Every study comprises a 4 hour basal period and a 2 hour Hyperinsulinemic-Euglycemic Clamp. Muscle and fat biopsies were obtained.

Study protocol 1 and Study protocol 2:

Assays: Mass spectrometry (15N-phenylalanine, 13C-urea), 3H-glucose, 3H-palmitate quantification, hormone and metabolite analysis, cytokine assays, intracellular signaling.

Eligibility Criteria:
Inclusion Criteria 1. group:

* Male
* 19 \< BMI \< 28
* 18 ≤ Age ≤ 50
* Healthy

Inclusion Criteria 2. group:

* Male
* 20 \< BMI \< 30
* Age \> 25
* Healthy

Exclusion Criteria:

* Diseases
* Allergy
Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve

Aim of this study is to compare learning curves of single(1- Jedi grip: Pappin and Christie/ 2- Bedforth/ 3- on lock: Gupta and Berrill) and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model.

Ultrasound-guided peripheral blocks are conventionaly performed by double operators. One operator controls both the ultrasound probe and peripheric block needle. Another assistant operator aspirate or injects local anesthetic. In this technique operator do not sense resistance in the syringe. Also this technique requires a well-done communication and coordination between operators.

In order to eliminate disadvantages of this technique several single-operator grip techniques of the needle and syringe have been described(1- Jedi grip: Pappin and Christie/ 2- Bedforth/ 3- on lock: Gupta and Berrill). Single operator techniques allow the provider to perform independently.

Aim of this study is to compare learning curves of single and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model.

Eligibility Criteria:
Inclusion Criteria:

- To be a junior resident of anesthesiology(\< 2 years )

Exclusion Criteria:

* Refusal of resident