cyrilzakka/clinical-trials huggingface dataset:
Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia

The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.

This is a non-interventional, multi-centre, longitudinal observation with a defined population using a prospective cohort design to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients currently under treatment with Retacrit™ (epoetin zeta) administered subcutaneously for renal anaemia.
* Informed consent given in writing after being provided with detailed information about the characteristics of this observation by the physician.
* Patients expected to be available for 3 years of observation

Exclusion Criteria:

* Any contraindications as per the current Summary of Product Characteristics (SPC) of Retacrit™
Lactate Values During Labour and Their Correlation With Maternal and Foetal Outcome

Postpartum haemorrhage (PPH) represents a significant cause of morbidity in the obstetric population, with a mortality rate of 140,000 women per year, and the predominant cause of PPH (70%) is uterine atony.

Consequently, elevated lactate levels during labour could influence maternal and foetal well-being. We decided to assess lactate concentrations during labour in women receiving neuraxial anaesthesia and evaluate the association between high lactate levels and adverse maternal and foetal outcomes.

The secondary aims of the study were to assess lactate levels at different stages of labour and investigate whether increased lactate concentrations could influence neonatal cord pH upon delivery.

We conducted a prospective observational single-centre study involving women in active labour receiving neuraxial anaesthesia.

Labour analgesia was placed at the beginning of active labour, whose definition follows the NICE guidelines. The labour analgesia technique consisted of standard epidural puncture or dural puncture epidural; the maintenance of analgesia was through clinician intermittent boluses given on maternal request.

Lactate levels were assessed via a venous blood gas test utilising an IV cannula already placed in the woman's limb upon admission.

These measurements were taken at three different time points, as follows: T0: at the time of diagnosis of the active phase of the first stage of labour, T1: at the beginning of the active phase of the second stage of labour, at the beginning of active pushing, and T2: at the time of the delivery, before placenta expulsion.

Postpartum haemorrhage (PPH) has been defined following the definition of the Royal College of Obstetricians and Gynaecologists as a total blood loss ≥ 500 ml.

To measure umbilical cord pH, 1-2 ml of cord blood were taken from the umbilical artery one minute after birth, regardless of clamping.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* single pregnancy with a gestational age of ≥ 36 weeks
* active labour with a cervix dilation of 4 to 6 cm
* neuraxial analgesia
* consent to the study Exclusion criteria
* \< 18 years
* twin pregnancy
* gestational age \< 36 weeks,
* labour without labour analgesia
* cervix dilation \> 6 cm at the moment of the placement of neuraxial analgesia
* not consent to the study
Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV

IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.

This is an observational prospective cohort study characterizing and establishing a biorepository of early treated children who may participate in future research related to HIV remission or cure. Early treatment is defined as treatment with at least three ARV agents from at least two classes of ART initiated within 12 weeks of birth. Within the overall study population, for descriptive and analysis purposes, children who initiated treatment within 48 hours of birth will be classified as having received very early treatment. A subset of children will have received bNAbs as part of their treatment regimens.

Up to approximately 250 children living with HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the US National Institutes of Health (NIH) will be enrolled and followed semi-annually for up to seven years. Clinical, virologic, and immunologic evaluations will be performed semi-annually at each study visit, and specimens will be collected for the study's biorepository for future investigations.

Eligibility Criteria:
Inclusion Criteria:

* Participated in one of the parent studies
* Confirmed HIV-1 infection based on documented nucleic acid testing of two blood samples collected at different time points
* Received early treatment for HIV-1 infection, defined as treatment with at least three ARV agents from at least two classes of ART, initiated within 12 weeks of birth
* Based on parent or guardian report at entry, child is expected to be available for at least 24 months of follow-up
* Parent or guardian is willing and able to provide written informed consent for child's study participation and, when applicable per institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written assent for study participation

Exclusion Criteria:

* Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe or otherwise interfere with completing study procedures
Cupping in Fibromyalgia

The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.

see above

Eligibility Criteria:
Inclusion Criteria:

* FMS diagnosis according to AWMF Guidelines,
* necessary documents: medical records
* Pain intensity \> 45mm VAS
* Participation in cupping twice weekly on appointment

Exclusion Criteria:

* pregnancy
* other study participation
* pain due to other rheumatic disease
* major psychiatric disorder
* substance abuse
* severe somatic disorder (cancer)
* injections, acupuncture, neural therapy within the past 3 months
ECMOsorb Trial - Impact of a VA-ECMO in Combination with CytoSorb in Critically Ill Patients with Cardiogenic Shock

In the ECMOsorb study the impact of a veno-arterial -ECMO in combination with an extracorporeal cytokine hemadsorption system in critically ill patients with cardiogenic shock is to be examined

The prospective, interventional, randomised controlled and blinded ECMOsorb study investigates in critically ill patinets with cardiogenic shock and with veno-arterial ECMO (VA-ECMO) treatment the impact of an extracorporeal cytokin hemadsorption system on hemodynamics, defined by the Inotropic Score 72 hours after initiation of the adsorber (intervention) or normal ECMO tube (control) in the VA-ECMO.

Eligibility Criteria:
Inclusion Criteria:

* Cardiogenic shock of any cause and indication for VA-ECMO
* Age between 18 and 80
* Signed informed consent

Exclusion Criteria:

* Current participation in another interventional trial
* Pregnancy
* Current immunosuppressive or immunomodulatory therapy
* Contraindications to VA-ECMO implantation.
* Patients with pre - existing sepsis (raised CPR, positive PCT, leukozytosis, fever, positive blood cultures).
* Shock duration\> 12 h before evaluation.
* Severe PVD (peripheral vessel disease) making ECMO-implantation impossible.
* Aortic valve insufficiency / stenosis at least II °.
* Age \> 80 years.
* CNS disease with fixed, dilated pupils (not drug-induced).
* Severe concomitant disease with limited life expectancy \<6 months.
* CPR\> 60min.
* Shock due to other reasons
* HIT positive (Heparin induced thrombocytopenia)
* Very low platelet counts (\< 20,000/µl)
* Body weight less than 45 kg
The Effects of Therapeutic Resources on Structure and Function of Normal and Burned Skin

Burning produces changes in the biomechanical properties of the skin causing limitation of movement. The increase in skin suppleness is very important in the rehabilitation process, since its increase makes therapeutic interventions aimed at increasing the range of motion, thus improving functional pattern. Will be evaluated 60 volunteers of both sexes aged 20-80 years seen at the Burns Unit of the Clinical Hospital of the Faculty of Medicine of Ribeirão Preto. There will be a traditional physical therapy evaluation as well as evaluation of the specific characteristics of the burn and scar. The temperature of the region will be assessed by thermography, and biophysical parameters and biomechanical skin evaluated by Cutometer and their accessory probes (mexameter, reviscometer, sebometer) before, immediately after and 10, 20 and 30 minutes of application of therapeutic resources. Volunteers will undergo continuous application of ultrasound with 3 MHz and intensity of 1 W/cm2 in the region due to scar deep second degree burn or third degree, and the application time of 2 minutes for each effective radiation area of the head (ERA) in a predetermined region of 9X5 cm a total of 4 minutes of application, therapy paraffin 20 minutes and 4 minutes endermology negative pressure between 100 and 200mmHg, in a continuous mode with glass head (1.5cm in diameter .) Applications will be set by random draw (design crusader cross-over) with an interval of 7 days between applications (wash-out). The data will be submitted to analysis of normality by the Shapiro-Wilk test, and the behavior of the effect between groups and pre-and post-intervention will be evaluated by two-way ANOVA followed by post-hoc (Bonferroni) or Friedman, p \<0.05


Eligibility Criteria:
Inclusion Criteria:

* Victims of deep second degree burns and third degree with a length of at least 1% of body surface area burned
* Postoperative graft skin (4 and 6 months)
* Anywhere in the body that has area to uninjured contralateral control
* Good state of physical and mental health
* Aged between 20 and 80 years
* Both genders
* Irrespective of race, class or social group

Exclusion Criteria:

* Volunteers with illnesses or deformities that may interfere with evaluation and procedures
* Volunteers which do not accept signing the Instrument of Consent and do not meet the inclusion criteria
The Prospective LEUVEN Transcatheter Valve Therapy Registry

Assessment of feasibility, safety and outcomes of transcatheter valve interventions

Transcatheter valve therapies have a growing impact on daily medical practice since the first human percutaneous implantation of an aortic valve bioprosthesis by A. Cribier in 2002. While initially these techniques were reserved for patients at prohibitive risk for surgical aortic valve implantation, indications moving toward patients at high and intermediate risk.

Outcomes of these percutaneous interventions need to be monitored to assess quality of care and tailor indications in this rapidly moving field in interventional cardiology.

Trial objectives and Design Trial objectives

* to describe patient populations selected for transcatheter valve treatment
* to describe procedural aspects and results
* to perform clinical and hemodynamic follow-up of the patients Primary endpoints The primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium criteria (2-3).

Secondary endpoints The secondary endpoints of the study are hemodynamic outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium criteria (2-3). Quality of life parameters, as well as exercise tolerance will be assessed.

Trial Design The design of the trial is a prospective non-interventional registry.

Eligibility Criteria:
Inclusion Criteria:

* All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry

Exclusion Criteria:

* All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry. There are no formal exclusion criteria.
Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation

The purpose of this study is to determine the safety and gastrointestinal pharmacodynamics (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation) of MD-1100 acetate administered daily for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-breastfeeding female, age 18-70 years old at the time of first dose;
* Sexually active patients of childbearing potential agree to use double-barrier birth control;
* Females of childbearing potential must complete negative pregnancy tests prior to first dose;
* Negative colonoscopy within 10 years or completion of negative flexible sigmoidoscopy if under the age of 50 provided there is no history of rectal bleeding, weight loss, or anemia;
* BMI must be greater than/equal to 18.5 and less than 35.0;
* Successful completion of physical exam, 12-lead ECG, clinical laboratory tests prior to first dose of study medication;
* Vital signs must not have clinically-significant findings within 4 hours of first dose of study medication;
* Patient reports 3 or less spontaneous bowel movements (SBMs) per week and meets 1 or more of the following criteria for constipation for 12 weeks in the previous 12 months: straining at least 25% bowel movements (BMs), lumpy or hard stools at least 25% of BMs, or sensation of incomplete evacuation at least 25% of BMs;
* Patient reports 3 or less SBMs during the 7-day Pre-treatment Period;
* Patient is compliant with IVRS for at least 6 days in the 7-day Pre-treatment Period.

Exclusion Criteria:

* Use of investigational drug within 30 days;
* Laxative/enema-induced diarrhea within 60 days;
* Patient meets ROME II criteria for functional diarrhea;
* Most bothersome symptom is moderate or severe abdominal pain or abdominal discomfort;
* History of cancer, inflammatory bowel disease, ischemic colitis, bowel resection, colostomy, or fecal impaction;
* Diagnosis of cathartic colon or laxative/enema abuse, pelvic floor dysfunction, evacuation disorder, bulimia, anorexia, or neurological disorders;
* Surgery within 30 days or GI surgery within 6 months of first dose of study medication. Cholecystectomy and/or appendectomy are acceptable if completed more than 60 days prior to first dose of study medication;
* Patient may not use any disallowed medications (prescription and/or over-the-counter treatments for chronic constipation or C-IBS, drugs that target 5-HT4, 5-HT2b, or 5-HT3 receptors, narcotics, anti-cholinergic agents, GI preparations, etc.) during the 7-day Pre-treatment Period or during the study. Stable, continuous (30 days or more) use of dietary fiber is acceptable.
* Any acute or chronic condition that would limit the patient's ability to complete and/or participate in the study.
Nutritional and Functional Assessment of Patients Undergoing Surgery Due to Gastrointestinal Cancer (NUFAGI).

Several patients that suffer from gastrointestinal (GI) cancer are characterized by malnutrition and impairment of their functional status. The aim of the present study is to evaluate the nutritional condition of patients undergoing surgery due to GI cancer and compare it with their functional status. All consecutive patients with esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer, that underwent a surgical operation will be included. Demographic characteristics, nutritional assessment and anthropometric measurements of the patients will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a surgical operation due to esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer.

Exclusion Criteria:

* Under 18 years old or above 99 years old.
* Surgery due to benign conditions.
A Study on Non-invasive Early Diagnosis of Gastrointestinal Stromal Tumors and Differentiation of Benign and Malignant Nodules

Gastrointestinal Stromal Tumors (GIST) is the most common mesenchymal tumor of the gastrointestinal tract, and the incidence rate in China has increased year by year in recent years.Gastrointestinal stromal tumors are not sensitive to radiotherapy and traditional infusion chemotherapy. Currently, they are generally treated with surgery, but they are prone to recurrence and metastasis.For nodules with a particle size between 2 and 5 cm, there may be both benign and malignant, and there is still a lack of fast and accurate methods for distinguishing benign and malignant.Many benign nodules were removed (in the pathological examination of postoperative resected tissue). In addition, if it is found to be late, there is a possibility of invading surrounding tissues and metastasis, so that it is impossible to cure. Therefore, early diagnosis and early surgery and benign and malignant differentiation of small nodules are the key to the clinical diagnosis and treatment of gastrointestinal stromal tumors.At present, second-generation gene sequencing (NGS) and liquid biopsy are rarely reported in the field of GIST. A few domestic and foreign studies have found that it can detect rare mutation types, and may find secondary gene mutations early, which has potential applicability, but Overall, the clinical guidance of these NGS-based studies focuses on prognosis and drug resistance , as well as some studies based on low-throughput platforms. Therefore, early diagnosis and benign and malignant discrimination based on high-throughput sequencing and liquid biopsy have significant clinical significance for the diagnosis and treatment of gastrointestinal stromal tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for stromal tumor resection
* Signed informed consent

Exclusion Criteria:

* the vital signs are not stable
* unconscious
* unwilling to cooperate
Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis

The purpose of the study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.

The primary purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the two primary efficacy variables 'proportion of recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within 96 weeks'.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of left-sided uncomplicated diverticular disease confirmed by computed tomography
* Presence of at least one diverticulum of the left colon
* Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months
* C-reactive protein (CRP) \> upper limit of normal (ULN) or leucocytosis at the start of the most recent attack

Exclusion Criteria:

* Complicated diverticular disease
* Right-sided diverticulitis
* Previous colonic surgery
* Presence of symptomatic organic disease of the gastrointestinal tract
* Active colorectal cancer or a history of colorectal cancer
* Hemorrhagic diathesis
* Active peptic ulcer disease, local intestinal infection
* Asthma if careful medical monitoring is not ensured
* Abnormal hepatic function or liver cirrhosis
* Abnormal renal function
Resistant Starch and Whey Protein on Energy Metabolism

Recent evidence shows that dietary supplementation with resistant starch (RS) increases fat catabolism and resting energy expenditure and decreases plasma insulin and glucose responses as well as the gut-derived hormone, glucose-dependent insulinotropic polypeptide (GIP). Consumption of whey protein has also been shown to increase energy expenditure and favorably affect gut hormones. Thus, investigators tested consumption of both RS and whey protein on energy expenditure and gut hormones in lean and obese women and men.

Consumed separately, resistant starch (RS) and whey protein (WP) favorably affect energy metabolism and gut hormones, as well as suppress feelings of hunger. These findings are important because release of certain gut hormones (i.e., GIP) is associated with a lower resting energy expenditure (REE) in healthy humans. Interestingly, a recent study showed that ingestion of RS reduces postprandial GIP and increases postprandial REE and fat utilization in healthy men and therefore may be an effective strategy in weight management. Thus, there is a need to replicate these findings in a healthy cohort of lean and obese women and men.

The purpose of this study was to examine the effects of RS on the number of calories burned after eating a meal, as well as specific hormones that are released from the stomach and intestines following meal ingestion in healthy lean and obese women and men. Investigators used a single ingestion of a meal supplemented with or without the resistant starch and whey protein.

Eligibility Criteria:
Inclusion Criteria:

* overweight or lean but otherwise healthy

Exclusion Criteria:

* Participants will be excluded if they smoke; have experienced excessive weight loss/gain of \> ±2kg in the previous 2 months; are currently taking medications for cardiovascular or metabolic disease.
Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study

This study evaluates and addresses challenges to implementing an acupuncture intervention for adults who have headaches after sustaining a moderate traumatic brain injury. Eligible participants will be recruited from Seattle and the surrounding areas to receive weekly acupuncture for 12 consecutive weeks. Participants will complete questionnaires to assess headache impact, depression, health-related quality of life, and cognitive function at the beginning of the study and every two weeks for the duration of the study. Participants will participate in structured interviews after the study for their views on the acceptability and tolerability of the study protocol.


Eligibility Criteria:
Inclusion Criteria

* Has a history of moderate traumatic brain injury (TBI) one to five years previously
* Currently under medical supervision for post-traumatic headache
* Have a score ≥ 3 on the Patient Health Questionnaire 2
* Have a raw summed score ≤ 6 on the PROMIS Cognitive Function Short Form v2.0 - Abilities 2a (part of PROMIS-29+2 Profile)
* Community-dwelling
* 18 years of age and older
* English Speaking
* Able to provide voluntarily consent

Exclusion Criteria

* History of multiple TBIs
* History of receiving acupuncture treatment in the past six months for the primary condition of headache
* An established diagnosis of PTSD
* Psychosis or agitation
* Other neurodegenerative disorders
* Other medical/surgical condition that precludes travel to participate in the intervention over the study duration
* Has an active skin lesion or acute trauma over or around the proposed acupuncture points
* History of trauma to the head that currently prevents the use of acupuncture points along the midline of the scalp
* Persons who are pregnant
* Unable to provide informed consent for the research as identified as answering more than two incorrect responses on the Six-item Screener