cyrilzakka/clinical-trials huggingface dataset:
Effects of In-utero Cord Blood Collection on Post-operative Hemoglobin Levels

Umbilical cord blood (UCB) collection and storage is a rapidly advancing field in hematology due to UCB's use for treatment of many hematological diseases, including but not limited to, Fanconi anemia, thalassemia, leukaemia and metabolic storage diseases. Primarily, there are two ways for UCB harvesting, first in-utero collection and second ex-utero collection. Depending on the amount of UCB collected, in-utero harvesting practice prolongs the operative time of cesarean delivery and speculatively increases intraoperative blood loss. The aim of this study is to determine UCB collection's effect on intraoperative bleeding in women undergoing elective cesarean delivery.

Elective cesarean deliveries that occurred in Ankara University Department of Obstetrics and Gynecology between March 2014 and February 2015 were enrolled in the study. Deliveries were divided into two groups depending whether cord blood was collected or not. All cesarean deliveries were performed via Joel-Cohen incisions. Cord blood was harvested in-utero, i.e. while leaving the placenta inside the uterus, after delivery of the baby and clamping of the cord. After UCB collection, placenta was delivered and hysterotomy site was repaired in one layer with continuous locking. Postpartum hemorrhage prophylaxis were performed with one dose of 0.2 mg methylergonovine maleate. Postoperatively patients were hydrated with 100cc per hour infusion of isotonic liquids and bloods were drawn at eight hours postoperatively for control blood counts. Amount of blood loss was estimated by subtracting preoperative hemoglobin and hematocrit levels from postoperative hemoglobin and hematocrit. Delta hemoglobin and hematocrit levels were compared between two groups. Correlation between amount of UCB collected and blood loss was also analysed.

Patients without a preoperative blood count within 30 days prior to delivery were excluded from the study, along with patients with history of bleeding 30 days prior to delivery. Emergent cesarean deliveries, postpartum bleeding due to uterine atony, retained placenta, cesarean deliveries performed due to placental adhesion abnormalities (placenta previa, placenta accreta), patients on anticoagulation regimens (aspirin, low molecular weight heparin, heparin), patients with a post-operative haemoglobin level higher than pre-operative levels were all excluded from the study. Patients were selected at random from birth register by two people who are blind to pre and post-operative blood count results.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean deliveries
* Women with a blood count results maximum 30 days prior to delivery

Exclusion Criteria:

* Emergent cesarean deliveries
* Cesarean deliveries due to placental adhesion abnormalities or placenta previa
* Patients on anticoagulation regimens
* Postpartum bleeding due to uterine atony, retained placenta
* Patients with a history of bleeding 30 days prior to delivery
Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From IBS Treated With Bifidice

Irritable bowel syndrome is the most common functional gastrointestinal disease and is characterized by high prevalence and chronic course.The pathology has a strong impact on the quality of life of affected patients and on health and social costs, these related to reduced productivity.The scarce efficacy and heavy side effects of traditional therapies lead these patients to often resort to alternative or complementary therapies. From the evaluation of the evidence of various probiotic preparations and food supplements, the investigators have used a commercial preparation characterized by the presence of bifidobacteria which have demonstrated some efficacy in thinking of improving the quality of life of these patients to evaluate quality of life, ability productivity and trend of some indices of disease severity in a small number of patients. These preliminary data could represent a starting point for more in-depth evaluations, also with placebo-controlled studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years
* Diagnosis of IBS according to Rome IV criteria
* Mild to moderate disease, as measured by FBDSI
* Absence of signs and symptoms that may suggest organic damage and, if indicated, negative instrumental investigations (colonoscopy and/or imaging)
* Prescription of Bifidice, according to normal clinical practice
* Informed consent expressed in written form

Exclusion Criteria:

* Patients undergoing surgical resection of the stomach, gallbladder, small or large intestine
* History of inflammatory bowel disease
* Severe SII, measured by FBDSI
* Active peptic ulcer
* History of ischemic colitis
* Active infectious enteritis
* Diagnosed with hypo- or hyperthyroidism
* Need for pharmacological treatments for IBS, antibiotics, antidepressants and laxatives
* Therapy in progress with drug or supplements included in the list of those not allowed (Paragraph N: to be established)
* Any disease that may affect gastrointestinal function and could interfere with appropriate assessment of abdominal pain or discomfort
Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma

For patients with progressive or recurrent glioblastoma there is no standard therapy. One strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity. In study arm A patients receive temozolomide for one week, followed by a week without temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a week without temozolomide. The regimen that is less toxic will be selected for further evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Progressive or recurrent glioblastoma documented by MRI no earlier than 180 days after first surgery for glioblastoma and no earlier than 90 days after completion of radiotherapy.
* Histological diagnosis of glioblastoma
* Tissue available for the determination of MGMT promoter methylation in the primary tumor or from the recurrent tumor if a patient undergoes a surgical procedure at recurrence prior to study entry.
* Prior treatment with temozolomide administered concomitantly with radiotherapy and at least for two cycles (5/28) as an adjuvant treatment
* Informed consent
* Age 18-80 years
* Karnofsky performance score \> 50%
* Neutrophil counts \> 1 500/µl
* Platelet counts \> 100 000/µl
* Hemoglobin \> 10 g/dl
* Serum creatinin \< 1.5-fold upper normal range
* ASAT or ALAT \< 3-fold upper normal range unless attributed to anticonvulsants
* Alkaline phosphatase \< 3-fold upper normal range
* Women with childbearing potential must have a negative serum pregnancy test ≤14 days prior to study enrollment
* Willingness to apply contraception according to local requirements (as stated in patient information)

Exclusion Criteria:

* Progressive or recurrent glioblastoma documented by MRI earlier than 180 days after first surgery for glioblastoma and earlier than 90 days after completion of radiotherapy.
* Treatment with any chemotherapy other than temozolomide according to the schedule of the EORTC NCIC trial (Stupp et al. N Engl J Med 2005;352:987-996) except that an adjuvant starting dose of 200 mg/m2 and more than 6 cycles of adjuvant temozolomide are allowed
* Prior systemic or local treatment with DNA-damaging agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer
* Allergy to or other intolerability of temozolomide
* Unable to undergo MRI
* Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
* HIV infection
* Pregnancy
* Breast feeding
* Treatment within in any other clinical trial parallel to the treatment phase of the current study
Healthy Living Through Personalized Monitoring of Eyelid Care

Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. The cloud database only allows access to administrator and will be password protected. You or your physician can monitor the frequency of eyelid warming over a long period.

Dry eye is a very common condition that can cause blurring of vision associated with reading, grittiness, eyelid heaviness and poor tolerance of light. Up to 80% of dry eye is due to blocked oil glands in the eyelids known as Meibomian Gland Dysfunction (MGD) and scientific studies have shown that sustained eyelid warming at 40-42°C for at least 8 minutes a day is effective to control this condition and increase the tear film layer thickness.

Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. The cloud database only allows access to administrator and will be password protected. You or your physician can monitor the frequency of eyelid warming over a long period. To further encourage eyelid warming to be performed more frequently, the signal can also be sent to a participating games server which hastens progress in the game. Thus, addiction to online games, which usually worsens symptoms of dry eye can now be a way to treat dry eye.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 21 years or older.
2. Subject must have severe MGD
3. Subject must be willing to answer the questions in the questionnaire
4. Subject must be willing to use the USB-powered eyemask as instructed
5. Subject must have the ability to provide informed consent
6. Subject must be willing to come back for follow-up visit

Exclusion Criteria:

1. Any other specified reason as determined by the clinical investigator.
2. Is pregnant, lactating or planning a pregnancy.
Study of a pd vWF/FVIII, Biostate®, in Subjects With Haemophilia A

The aim of this study are to

* assess the efficacy of Biostate® \[Study Product (SP)\] in subjects with Haemophilia A
* compare the pharmacokinetics of Biostate® \[SP\] with the previously marketed product Biostate® (here referred to as Biostate® \[Reference Product (RP)\]).

This study is divided into 3 parts:

Part 1: Cross-over pharmacokinetic (PK) component. PK subjects will be randomised to determine the order in which they receive the two study products. This part of the study is double-blinded.

Part 2: Efficacy component. All subjects will receive Biostate® \[SP\] as required to manage their haemophilia condition for an estimated period of 6 months (or minimum of 50 exposure days) to assess efficacy and safety of the product. This part of the study is open-label.

Part 3: Repeat pharmacokinetic assessment. Subjects who participated in Part 1 (PK component) will undergo a repeat PK assessment on Day 180 following administration of Biostate® \[SP\].


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Haemophilia A with ≤ 1% Factor VIII (FVIII) levels in the absence of factor replacement
* Evidence of vaccination against hepatitis A and B (or presence of antibodies against hepatitis A and B due to either a previous infection or prior immunisation) within 10 years prior to Day 1 documented in the medical notes
* At least 150 days of prior exposure to a FVIII replacement product
* Written informed consent given

Exclusion Criteria (for participation in the pharmacokinetic (PK) component):

* Active bleeding
* Body weight \> 100 kg

Exclusion Criteria (for all subjects):

* Receipt of an infusion of any FVIII product, cryoprecipitate, whole blood, plasma, or desmopressin acetate (DDAVP) in the 4 days prior to Day 1
* Known history of FVIII inhibitors, or FVIII inhibitor level \> 0.6 Bethesda Units (BU) at screening
* Receipt of aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 7 days of administration of study product.
* CD4 lymphocytes \< 200/µL. Subjects wo are HIV-1 positive may be considered for the study if viral load ≤ 200 particles/µL at screening and all other eligibility criteria are met.
* Impaired liver function ie. bilirubin \>1.5 x upper limit of normal (ULN) and/or AST/ALT \> 2.5 x ULN at screening.
* Acute or chronic medical condition, other than haemophilia A, which may, in the opinion of the Investigator, affect the conduct of the study
* von Willebrand Disease (VWD) with Von Willebrand Factor:Ristocetin Cofactor (vWF:RCo) level \< 50 IU/dL at screening
* Evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit
* Known or suspected hypersensitivity or previous evidence of severe side effects to Biostate®, FVIII concentrates or human albumin
* Participation in a clinical study or use of an investigational compound (e.g. a new chemical entity not approved for clinical use) in the 3 months preceding the first day of study drug administration, or plans to enter such a study during the study period
* Not willing and/or not able to comply with study requirements
Tool for Sibling and Children of Someone With Suicidal Thoughts

This study aims to investigate to what extent a website developed for siblings and children (16-25 years old) of someone with suicidal thoughts and/or behaviors is effective in improving perceived pressure, knowledge, attitudes, self-confidence and hopelessness. Moreover, it aims to examine how participants evaluate the website.


Eligibility Criteria:
Inclusion Criteria:

* Siblings and children of someone who has suicidal thoughts and/or behavior
* 16-25 years old
* Have access to internet
* Speak Dutch

Exclusion Criteria:

* /
The Relation Between Preoperative ScO2 and the Postoperative Course of Humoral Organ Dysfunction Markers.

Cerebral oxygen saturation (ScO2) is a measure of cerebral and systemic oxygen delivery to demand ratio. An observational trial in a heterogeneous cohort of 1078 patients patients revealed that a ScO2 below 50% absolute during oxygen insufflation is an independent predictor of short and long term mortality in patients undergoing on-pump cardiac surgery. Comparably, a low ScO2 was a predictor of postoperative morbidity determined as a combined endpoint of a high dependency unit stay of more than 9 days and/or at least 2 of the major postoperative complications. low cardiac output syndrome, stroke, need of renal replacement therapy or reintubation.

The primary objectives of the present prospective observational study is to determine, if there is an association between preoperative ScO2 and postoperative organ dysfunction determined by sensitive markers of organ dysfunction (N-Terminal pro B-type natriuretic peptide, high sensitive troponin T, growth-differentiation factor 15, soluble -FLT1, and placental growth factor)


Eligibility Criteria:
Inclusion Criteria:

* all patients scheduled for cardiac surgery

Exclusion Criteria:

* age less than 18 years
Impact of Chronic Circadian Disruption vs. Chronic Sleep Restriction on Metabolism

The overall objectives of the proposed study are to examine the consequences of chronic circadian disruption and chronic sleep restriction on metabolic function in healthy adults.

It has long been recognized that sleep patterns change with age. A common feature of aging is the advance of the timing of sleep to earlier hours, often earlier than desired. These age-related changes are found in even healthy individuals who are not taking medications and who are free from sleep disorders. In addition to these sleep disturbances, many older individuals curtail their sleep voluntarily, reporting similar rates of sleep restriction (sleeping less than 7 or less than 6 hours per night) when compared to young adults. Whether voluntary or not, insufficient sleep has medical, safety and metabolic consequences. In fact, converging evidence in young adults suggests that sleep restriction per se may impair metabolism, and that reduced sleep duration is associated with weight gain, obesity, diabetes, cardiovascular disease, and mortality. An understanding of how the circadian and sleep homeostatic neurobiological processes responds to increasing homeostatic sleep pressure, and the effects of sleep restriction on metabolism at different ages, should provide information on the regulation of sleep and metabolism in aging, as well as direction for future treatments. In the present study, we will study the separate impacts of chronic sleep restriction (while minimizing circadian disruption) and chronic circadian disruption (while minimizing sleep disruption) and a poor diet on metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with conventional and regular sleep-wake timing
* Non-smokers
* Completion of medical, psychological, and sleep screening tests
* Able to spend 37 consecutive days/nights in the laboratory

Exclusion Criteria:

* History of neurological or psychiatric disorder
* History of sleep disorder or regular use of sleep-promoting medication
* Current prescription, herbal, or over-the-counter medication use
* Traveling across 2 or more time zones within past 3 months
* Donating blood within past 8 weeks
* Worked night or rotating shift work within past 3 years
* Hearing impairment
* Drug or alcohol dependency
Simulator Training for Gastrointestinal Endoscopy

This is a randomized controlled trial evaluating three training intervals using an endoscopy simulator for novices and comparing performance after training.

Randomized controlled trial evaluating different training intervals on an endoscopy simulator and comparing performance using a validated score (Global assessment of Gastrointestinal Endoscopic Skills). Physicians participating in the study are novices with no previous experience in flexible endoscopy. Subjects are randomized into three different training arms. Proficiency scores will be evaluated by a supervising physician blinded to group allocation.

Eligibility Criteria:
Physicians in residency or fellowship programs requiring training in flexible endoscopy (gastroenterology, internal medicine, surgery) with no experience in flexible endoscopy
Studying Patterns in Patient Engagement Among Tardive Dyskinesia Patients

The statistical analysis of the collected data aims to reveal the many factors that influence patient involvement in clinical trials. Findings will be disseminated through conferences and scholarly papers to benefit all parties participating in clinical trials.

These findings will help to shape the design of future clinical trials for people with tardive dyskinesia, as well as enhance recruiting techniques and retention rates.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of tardive dyskinesia
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* No prior treatment for tardive dyskinesia

Exclusion Criteria:

* Enrolled in another research study
* Inability to provide written informed consent
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty

Total knee arthroplasty is a frequent surgery in France. It currently represents 70,000 interventions per year. The total knee prosthesis is also called tri-compartmental because it allows articulation between the femur and the tibia but also between the femur and the patella.

The patella belongs to the extensor system. It articulates with the femoral trochlea in which it slides. It has an important biomechanical role on the quadriceps strength in addition to allowing flexion-extension movements.

In the case of resurfacing, the joint face of the patella is cut off; A convex polyethylene implant is sealed with cement using studs on the same face.

In case of non-resurfacing, the surgeon leaves in place the cartilage of the patella which will be in direct contact with the femoral prosthetic trochlea.

Both methods have advantages and disadvantages. For some implants, it is recommended to resurface the patella because the implant is not very tolerant with the native patella. Other implants have been designed to be better adapted to the preservation of patellar cartilage.

There is currently no evidence that one method is superior to the other on new generation implants known as "patellar friendly".

It seems necessary to compare both methods in terms of long-term postsurgery results.

The analysis of the primary endpoint (International Knee Society score (IKS score)) will be based on the assumption that the postsurgery score will be identical in both groups. The t test for independent samples will be used to test this hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female (age ≥ 18 years)
* Diagnosis of knee arthrosis (internal femoro-tibial arthrosis, external femorotibial osteoarthritis, femoro-patellar arthrosis)
* Indication of total first-line knee arthroplasty

Exclusion Criteria:

* Patient whose surgical complexity requires the placement of a strained prosthesis (ligament laxity, bone loss).
* Refusal to participate in the study
* Pregnant women, parturients or nursing mothers
* Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research
* Minor Patients
* Major persons who are subject to a legal protection measure or are unable to express their consent
* Patient not affiliated to a social security scheme
* Patient participating in other interventional research excluding routine care studies not interfering with analysis of primary endpoint