cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Sensor for Core Temperature Measurement

Soldiers are required to perform and maintain alertness in difficult environmental conditions. The sensor examined in this trail may indicate body core temperature elevation during exertion. 12 male volunteers will arrive to our lab and perform a protocol of sitting and walking in thermoneutral and hot environments with two core temperature sensors. The results obtained from them will be compared.

During the protocol the volunteers will sit in thermoneutral condition for 30 minutes, than they will sit in hot chamber (40 celsius and 40% relative humidity). Afterwards, the participants will walk on a treadmill in 5 km/hr and 4% incline for one hour. The participants will be connected to rectal thermistor which is considered the "gold standard" and to the new noninvasive sensor which is attached to the skin surface.

Eligibility Criteria:
Inclusion Criteria:

* age 18-25 - healthy
* after medical checkup
* after signing concent form
* with no heat stroke medical history

Exclusion Criteria:

* heat stroke medical history
* heart disease
* diabetes
* obesity
Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

The purpose of this randomized double blind controlled study is to assess the value of robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare perioperative and functional outcomes to the laparoscopic approach.

Pelvic floor dysfunction is a common pathology. The management can be medical or surgical, depending on the location or the severity of the disease.

Since the large use of laparoscopy for the treatment of pelvic floor dysfunction, interesting and encouraging results have been published.

However, so far, a laparoscopic approach has some technical disadvantages like a poor ergonomy, a 2 dimensional vision, an unstable camera and the use of straight instruments. To overcome these natural limitations, robotics has been gaining increasing acceptance in general surgery.

Several groups have reported their encouraging experience with robotic rectopexy. Yet, these studies were not randomized or double blinded.

The aim of this study is to evaluate the role of robotics for complex pelvic floor dysfunction and to compare the outcomes to the laparoscopic approach.

Eligibility Criteria:
Inclusion Criteria:

* women
* proven pelvic floor dysfunction
* informed consent

Exclusion Criteria:

* Age \<18 years old
* Patient unable to communicate or to understand the study
* Patient refusing to participate to the study
* contraindication to laparoscopy
Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients

This crossover study will investigate the pharmacokinetics of oral versus sublingual administration of 17-beta-estradiol in the trans-female population.


Eligibility Criteria:
Inclusion Criteria:

* English speaker
* Currently taking 17-beta-estradiol tablet daily via sublingual or oral route on dose therapeutic for gender-affirming therapy; steady dose for at least 4 weeks
* Serum estradiol and testosterone levels within target therapeutic range (75-200 pg/mL and \<55 ng/dL, respectively)

Exclusion Criteria:

* Active or history of deep venous thrombosis/pulmonary embolism
* Active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)
* Liver dysfunction
* History of breast cancer
* History of orchiectomy
* Known sensitivity or allergy to any components of the study medication
* Taking potent CYP3A4 inhibitors or inducers
Carbetocin at Elective Cesarean Delivery

Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published.

We hypothesize that a dose-response study will establish the minimum dose of carbetocin required to produce appropriate contractility in 95% of the women (ED95) undergoing elective cesarean delivery.

The Society of Obstetricians and Gynecologists of Canada (SOGC)recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery. However, a dose response study to determine the minimum effective dose of carbetocin has not yet been published.

Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effects profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin.

The results of this study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.

Eligibility Criteria:
Inclusion Criteria:

* All patients planned for elective cesarean delivery under spinal anesthesia;
* All patients who gave written informed consent to participate in this study.

Exclusion Criteria:

* All patients who refuse to give written informed consent.
* All patients who claim allergy or hypersensitivity to carbetocin or oxytocin.
* All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.
* All patients with hepatic, renal, and vascular disease,
* All patients requiring general anesthesia prior to the administration of the study drug.
Repair Versus Augmentation of Partial ACL Tear

Comparison between ACL repair and ACL augmentation in symptomatic patients with partial ACL injury


Eligibility Criteria:
Inclusion Criteria:

* age from 15 to 50 years old
* Partial ACL tear without any other ligament injury
* with and without meniscal tear
* with and without knee deformity
* recent and chronic injury

Exclusion Criteria:

* younger than 15 and older than 50 y
* multiligament injury
* complete ACL tear
* failed ACL reconstruction or repair
Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock

The study compares the therapies of instant multivessel balloon angioplasty plus stent implantation or the balloon angioplasty plus stent implantation of the infarct artery alone with any possible graduated later treatment of the other vessels in patients with acute myocardial infarction with cardioganic shock.

The main study hypothesis is to explore if culprit vessel only PCI with potentially subsequent staged revascularization in comparison to immediate multivessel revascularization by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces the incidence of 30- day mortality and/or severe renal failure requiring renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI) with obligatory:

I) Planned early revascularization by PCI II) Multivessel coronary artery disease defined as more than 70% stenosis in at least 2 major vessels (more than 2 mm diameter) with identifiable culprit lesion III)

1. Systolic blood pressure less than 90 mmHg for more than 30 min or
2. catecholamines required to maintain pressure more than 90 mmHg during systole and IV) Signs of pulmonary congestion V) Signs of impaired organ perfusion with at least one of the following criteria

a) Altered mental status b) Cold, clammy skin and extremities c) Oliguria with urine output less than 30 ml/h d) Serum-lactate more than 2.0 mmol/l VI) Informed consent

Exclusion Criteria:

* Resuscitation more than 30 minutes
* No intrinsic heart action
* Cerebral deficit with fixed dilated pupils (not drug-induced)
* Need for primary urgent bypass surgery (to be determined after diagnostic angiography)
* Single vessel disease
* Mechanical cause of cardiogenic shock
* Onset of shock more than 12 h
* Massive lung emboli
* Age more than 90 years
* Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
* Other severe concomitant disease with limited life expectancy \<6 months
* Pregnancy
* Known severe renal insufficiency (creatinine clearance \<30 ml/kg)
Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules

During the VATS procedure, some pulmonary nodules are relatively small or far away from the pleura, resulting that they are difficult to be accurately located during the procedure.

The aim of this study is to evaluate the efficacy and safety of using disposable pulmonary surgical markers to localize pulmonary nodules in subjects prior to the resection of pulmonary nodules by video-assisted thoracoscopic surgery (VATS).

It is a prospective, multicenter, single group target value clinical trial. The subjects will undergo VATS within 24h after the placement of the Marker, then the Marker and targeted nodule will be removed during VATS. Subjects will be followed up intraoperatively, immediately after placement procedure to the end of VATS resection, 7 days after placement procedure/before discharge (whichever occurs earlier), and 30 days after Marker placement procedure. Demographic and baseline information of subjects, immediate operation success rate of marker placement, positioning success rate, and adverse events will be collected and recorded in this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old；
* Pulmonary nodule, which satisfying any of the following Criteria:

  * solid nodules with diameter ≤1 cm or solid component ≤1 cm non-purely ground glass, and the distance between the solid component of the nodule and the visceral pleural\>0.5cm;
  * Pure ground glass opacity (pGGO)；
  * Before VATS operation, the doctor judge that the nodule is difficult to locate during the operation.
* Pulmonary wedge resection or Segmental pulmonary resection under VATS is proposed;
* Preoperative evaluation shows that placing marker through bronchus is feasible；
* The subject is able to fully understand the requirements of clinical research;
* Subject or the legal representative signs the informed consent form.

Exclusion Criteria:

* Contraindications for bronchoscopy;
* Systemic factors: sepsis, history of repeated pulmonary infections, and any type of severe infectious disease within one month of screening；
* Severe cardio and pulmonary disease；
* Coagulation dysfunction, with a clear tendency to bleed;
* General anesthesia contraindication;
* Allergic history of nickel-titanium materials;
* Breast-feeding or may be or plan to be pregnant during the trial;
* Participating in clinical trials of other drugs or medical devices;
* Other conditions that Investigator consider the subject to be inappropriate.
A Study to Improve the Collaboration Between Primary and Secondary Health Care on the Treatment of Osteoporosis After a Hip Fracture.

This is a study to improve the collaboration between primary and secondary health care on the treatment of osteoporosis after a hip fracture. In Akershus University Hospital, patients 75 years or older with a hip fracture, are offered treatment with an infusion of zoledronic acid 5mg, combined with vitamin D and calcium supplements, to prevent new fractures. General practitioners (GPs) are requested to take care of the follow-up on this treatment with annual infusions of zoledronic acid for 3 years.

In the opinion of the investigators, it is expedient, safe, and sensible for parts of the subsequent treatment to be provided by GPs. If hospitals take responsibility for initiating the treatment, the investigators believe that most of the subsequent monitoring and continuance of treatment can be conducted by the primary healthcare service. Despite this, the investigators suspect that many patients do not get their annual infusions of zoledronic acid after discharge from the hospital.

This quality assurance study aims to test a new system where ambulant nurses from the hospital support the GP in treating osteoporosis with the administration of zoledronic acid in the following 3 years after femoral neck fractures. Through the project, the investigators will create procedures for the administration and follow-up of zoledronic acid fitted in the setting of the GP office.

The design is a cluster randomized controlled study (RCT) where the regions are prospectively randomized to either intervention or control regions. Patients ≥ 75 years, which suffer a femoral neck fracture, are identified in our Department of Orthopedic Surgery, where they are provided the first infusion of zoledronic acid 5 mg and proposed participation in the study. Patients from the intervention regions will be followed by the protocol of ambulant nurse-assisted administration of zoledronic acid. Patients from the control regions are offered the usual care. Both patients from the control and intervention regions are asked to fill out a questionnaire after 1 year. The questionnaire will ask if the patient has got zoledronic acid as encouraged in the medical journal after discharge from the hospital. The primary study outcome is if the patients are offered treatment at a one-year follow-up or not.

Sample size calculation estimates a total sample of 130 patients based on a minimal clinically important difference of 20% follow-up between the groups. Because of high mortality, the investigators estimate the need for 200 patients.

The investigators hypothesize that the one-year follow-up is better in the intervention group than in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients 75 years or older with a hip fracture

Exclusion Criteria:

* Refuse treatment
* Another treatment of osteoporosis is indicated
* Guest patient, do not live in the admission area
* Dementia
Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression

The aim of this randomized, single-blind trial is to evaluate the effectiveness and tolerability of high frequency or low frequency repetitive transcranial magnetic stimulation (rTMS) in patients with resistant bipolar depression. Patients will be assigned to receive either high or low frequency rTMS for 20 consecutive workdays (4 weeks). 10 Hz (high) frequency rTMS and 1 Hz (low) frequency rTMS will be given over the left or right dorsolateral prefrontal cortex (DLPFC), respectively. Patients will be assessed with several psychometric instruments at baseline, and at weeks 5 and 9.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 70 years
* Current major depressive episode (MDE) in the context of a bipolar disorder type I or II (according to the DSM-IV-TR) that has not improved after more than 2 adequate pharmacological trial(s) in the current episode (failure is defined as a lack of significant clinical improvement after the use of standard mood stabilizers, atypical antipsychotics and/or antidepressants given at their minimum effective dosage or higher for at least 4 weeks of duration)
* Baseline score ≥ 13 on the Quick Inventory of Depressive Symptomatology - Clinician-Administered (QIDS-C), i.e., a MDE of at least moderate intensity

Exclusion Criteria:

* Psychotic features in the current episode
* Lifetime history of a non-mood-related psychotic disorder
* Substance or alcohol abuse/dependence in the past 6 months
* Unstable medical disease (e.g., cardiovascular, renal)
* Presence of mood cycles of \< 30 days duration
* Pregnancy and/or lactation
* Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy or convulsion, metallic head implant)
* Hearing loss
Effect of Weight and/or Obesity on Caspofungin Drug Concentrations

This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, age 18 years of age or older, of all racial and ethnic origins. English and/or Spanish speaking volunteers are eligible to participate.

Exclusion Criteria:

* Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of caspofungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of caspofungin, so that the pregnancy and post-partum state would be a confounding variable.
* Abnormal liver function tests: transaminases\>10 times upper limit of normal, Alkaline phosphatase\>5 times upper limit of normal, total bilirubin\>5 times upper limit of normal.
* History of allergies to echinocandins.
* Echinocandins are contraindicated for any reason.
* Volunteers unwilling to comply with study procedures.
* Suspected or documented systemic fungal infection.
* Concomitant use of rifamycins, tacrolimus, or cyclosporine
A National Study for Blood Based Response Monitoring of B-cell Lymphoma Patients

Observational prospective study. Patients with DLBCL and HGBCL will be enrolled in the study to collect samples for developing a blood based assay allowing biomarker driven treatment in the future.

The rationale of this study is that, due to the lack of successful salvage options, first-line treatment outcome needs to be improved. To make this possible, a crucial condition is optimal identification of patients that will not be cured on R-CHOP. The aim of this protocol is to develop new tools to monitor treatment response and disease outcome. Molecular monitoring of treatment response through liquid biopsies (LB) is such a promising new tool.

The primary objective is to collect liquid biopsy samples of patients with newly diagnosed DLBCL/HGBCL to develop a blood based assay allowing biomarker driven treatment in the future.

The secondary objectives are to collect clinical data and pre-treatment tissue samples (for determining molecular profiles) to allow for correlation to the blood based assay.

This study is designed for patients with newly diagnosed DLBCL and HGBCL ≥ 18 yr.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with newly diagnosed DLBCL (including HGBCL- NOS and HGBCL-DH) according to WHO classification 2016
* Ann Arbor stage II-IV
* Patients intended to be treated with 6 cycles R-CHOP (or DA-EPOCH-R) as first-line treatment (successive inclusion in HOVON 151 or HOVON 152 is possible)
* Age ≥ 18 years

Exclusion Criteria:

- Patients with limited stage I, II disease planned to receive 3 cycles of R-CHOP + radiotherapy, or 4 x R-CHOP+ 2R
Effectiveness of a Smartphone App for Adolescent Obesity Management

Though face-to-face treatment of childhood obesity can be effective, it is time consuming and costly. This study will test whether treatment can be delivered via an Android app and whether such treatment reduces obesity.


Eligibility Criteria:
Inclusion Criteria:

* child aged between 12.0 and 17.0 years,
* child BMI =/\> 98th percentile,
* first language is English (or fluent in English)
* parent/s willing to participate in the programme with their child
* completion of written informed consent and/or assent prior to any study-specific procedures

Exclusion Criteria:

* severe intellectual difficulties,
* obesity secondary to genetic condition,
* limitations to engaging in physical activity
* use of medication known to effect body weight;
* limitations to using a smartphone device
* known family issues that would affect general compliance and attendance at follow-up visits.
Novel Equation for Estimating Intraperitoneal Pressure

Intraperitoneal Pressure is associated with the complications of increased intra-abdominal pressure in peritoneal dialysis patients. Due to the complicated operations, routine measurement of hydrostatic intraperitoneal pressure is not used routinely in adult peritoneal dialysis patients. There ars some limitions in equations from previous studies, such as the sample size was small , and the study population was limited. In the study, we aim to develop and validate an equation for estimating intraperitoneal pressure in peritoneal patients.


Eligibility Criteria:
Inclusion Criteria:

* Peritoneal dialysis patients
* Dialysis length \>1 month
* Aged 18-80 years
* Injection volume of peritoneal dialysis solution\>1500ml

Exclusion Criteria:

* Acute complications （ peritonities, cardiovascular and cerebrovascular diseases) to hospitalization 1 month prior to the study
* History of abdominal surgery and trauma 1 month prior to the study
* Previous history of hernia, leakage, or thoracoabdominal fistula
* Can't come for a follow-up visit
Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work

Thoracic outlet syndrome may associate neurologic, arterial and venous symptoms. The responsibility of repetitive movements and postural factors has been mentioned for long. Some tasks are hard to perform, and it seemed interesting to assess the consequences of this syndrome on the work capacity by a questionnaire, at the moment of diagnosis by Echo-Doppler


Eligibility Criteria:
Inclusion Criteria:

* A stenosis of at least 80% of arterial stenosis at Echo-Doppler examination during abduction-retropulsion of the arm
* Actually employed or having been employed

Exclusion Criteria:

* Cognitive or mental impairment
* Illiteracy
* Visual impairment
* Patients having been diagnosed with fibromyalgia, chronic fatigue syndrome or ehler-Danlos syndrome
Intra Amniotic Injection of DIGOXIN for Feticide in Second Trimester Termination of Pregnancy

In second trimester abortion above 22 weeks the investigators usually inject intra-cardiac Kcl for feticide. Digoxin intra-amniotic injection has been described in the literature in doses of 1-1.5 mg. with a success rate of about 80%, and up to 24 weeks. Our aim in this study is to investigate the safety and success rate of 1.5-2 mg. digoxin, intra-amniotic up to 30 weeks pregnancy .

* The digoxin will be injected intra-amniotic with U.S guided, trying to avoid any placental passage or intravascular injection /
* Any patient will have prior to the procedure a full examination including E.C.G and cardiac clearance.

Eligibility Criteria:
Inclusion Criteria:

* healthy women with no medical, cardiac, hypertension, liver or renal problems - pregnant in their 20-30 week gestation,
* that need to have abortion due to fetal anomalies or any other reason
* need to have feticide prior to the procedure

Exclusion Criteria:

* any patient with medical problem that may be a contra-indication to Digoxin
* cardiac problems,
* prior cardiac surgery,
* liver or kidney disease,
* hyper tension etc.