cyrilzakka/clinical-trials huggingface dataset:
Fatigue Test With an XCo

The reliability of the Xco endurance test will be assessed in sedentary adults and in overhead athletes. The experimentation will be divided into two sessions. During the sessions, the impact of the test on rotators strength and throwing performance will be explored.

At first, the reliability of the Xco endurance test will be assessed in sedentary adults. Then, the reliability of the test will be assessed in overhead athletes. The experimentation will include two sessions. During those sessions, the impact of fatigue (induced by the test) on rotator cuff muscles strength and on functional test performance (Single Arm Medicine Ball Throw) will be assessed. A time of 7 to 10 days will be provided between the two sessions.

To perform the XCo endurance test, the participant will be seated on a chair, arm at 90° of abduction (in frontal plane), elbow flexed at 90 degrees and positioned on a wooden support. From a 90 degrees of abduction and a neutral position of rotation, the participants will be asked to realise an external rotation movement of 90 degrees and then to go back to the starting position as many times as possible at a speed of 140 bpm. Mechanical stops (the wall and an adjustable height table) will be added to make sure that the participants respected the entire range of motion. After adjusting the position, it will be asked to the participants to perform 2 repetitions of 5 movements at 140 bpm (in eccentric and concentric) to get familiar to the rhythm. Thirty seconds of rest will be provided between the 2 repetitions to avoid the appearance of fatigue before the test.

Then, the participants will begin the test. The objective of the test will be to perform the movement as long as possible. The test will be stopped if the volunteers is not able to maintain the rhythm or to do the movement anymore. The Modified Borg Scale will be used to be sure that each subject was really exhausted when the test was stopped. For that purpose, each of them will have to quantify their level of exhaustion on the scale (maximum score = 10) every 30 seconds.

Eligibility Criteria:
Inclusion Criteria:

* Practice of an overhead sport at least 5 hours a week (overhead athletes group)
* Not practice an overhead sport (sedentary adults)

Exclusion Criteria:

* History of shoulder pain
* Shoulder pain
Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)

Allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral arterial disease (PAD)

Allogenic platelet rich plasma (PRP) will be collected from blood group AB donors. This plasma will be tested for the presence of any chronic infectious blood borne disease.

Platelet lysate will be then prepared from the tested PRP to be intramuscularly injected in patients with PAD

Eligibility Criteria:
Inclusion Criteria:

* Competent and willing to give informed consent, and to be available for all baseline treatment and follow up examinations required by the protocol.
* Gender: Male or female.
* Age group \> 50 years.
* Established Critical limb ischemia (CLI), clinically and hemodynamically confirmed as per Rutherford 3, 4 and 5 with angiographic evidence of significant infra-inguinal arterial occlusive disease.
* History of intermittent claudication for \> eight weeks.
* Limited exercise due to moderate to severe claudication.
* Resting ABI \< 0.6, toe pressure ≤ 60 mm Hg, Toe Brachial index (TBI) \<0.6, or TcPO2 ≤ 60 mmHg in the foot.
* Not eligible for surgical or radiological revascularization, and doesn't respond to best standard care delivered as confirmed by a vascular surgeon and/or physician.
* Fairly controlled diabetes (Hemoglobin A1c \<10%).
* Normal liver enzymes, serum creatinine \< 1.4
* Normal platelet count.
* On regular medication for hypertension if any.
* No evidence of malignancy
* Body mass index \<30.

Exclusion Criteria:

* Women with child bearing potential, pregnant and lactating women.
* Rheumatoid Arthritis.
* History of neoplasm or malignancy in the past 10 years.
* Reported unstable cardiovascular disease, heart failure or symptomatic postural hypotension within 6 months before screening.
* Leg edema
* Inflammatory or progressive fibrotic disorder
* Renal insufficiency or failure
* History of infectious disorder (Human immunodeficiency virus (HIV) and/or hepatitis viruses).
* Chronic inflammatory disease
* History of stroke or myocardial infarction (\< 3 months).
* Bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).
CBT for Pediatric OCD: Community Training Pilot

This study examines a training program for clinicians who work in mental health clinics that serve children with OCD. We will provide clinician training in conducting exposure-based treatments for children with OCD. The purpose of the project is to test the use of a new tool to enhance training in exposure-based treatments for clinicians. Therapists will receive training and oversight from the researchers regarding the treatment procedures and use of the new tool. All children enrolled in the study will receive treatment by clinicians who are participating in this study. Therapists and youth will be recruited separately for the study and will be assigned to work together.


Eligibility Criteria:
Inclusion Criteria:

* Obsessive Compulsive Disorder is primary diagnosis

Exclusion Criteria:

* Diagnosis of Psychosis, Pervasive Developmental Disorder, or Mental Retardation
Postplacental LNG-IUD Ultrasound Use Study

This study will enroll women planning to have an intrauterine device (IUD) placed for contraception immediately following a vaginal delivery. Women will be randomized to have this procedure done with or without ultrasound guidance. We intend to determine if the routine use of ultrasound to confirm device position reduces the rates of IUD expulsion.

Participants will be screened and consented for participation in the study when they are admitted to Labor and Delivery for delivery and express desire for a post-placental LNG-IUD. If the patient consents for study participation and meets eligibility criteria above, she will be enrolled in the study after achieving vaginal delivery when she is randomized to either IUD insertion with ultrasound or without ultrasound use. See protocol for detailed description of IUD placement and ultrasound use.

After placement of IUD with or without ultrasound guidance, patients will be scheduled for a routine postpartum follow-up visit 6-10 weeks after delivery. At the postpartum follow-up visit, providers will assess for IUD expulsion with usual clinical practice, including history, pelvic exam, and additional imaging if IUD strings are not visualized on exam. Several attempts to contact participants who do not attend their postpartum visits will be made to attempt to reschedule appointments and conduct a phone questionnaire assessing for IUD expulsion.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Thomas Jefferson University Labor and Delivery who desire and consent to post-placental LNG-IUD placement
* English- and Spanish- speaking patients

Exclusion Criteria:

* Patients undergoing planned or unplanned Cesarean delivery
* Patients who have an allergy or other contraindication to use of LNG-IUD
* Patients who tested positive for gonorrhea or chlamydia during pregnancy without treatment and a subsequent negative test of cure
* Patients with one or more leiomyomata greater than 3 cm in diameter impinging the uterine cavity
* Clinical diagnosis of chorioamnionitis or presumed chorioamnionitis in labor
* Postpartum hemorrhage as defined by need for transfusion, estimated blood loss greater than 1000mL, or use of 3 or more doses of uterotonic medications
Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion Total Intravenous Anesthesia With Propofol

Closed-loop infusion system for target controlled infusion of propofol by using TCI pump designed by BD Technology. (Germany) guided with entropy and surgical pleth index (GE) will not only prevent awareness from Anesthesia but also optimise the dose anesthetic agents based on feedback from adequacy of Anesthesia monitoring. Which not only reduces Anesthesia agents but also enhances recovery from Anesthesia. Innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of Entropy.In this study we performed a randomized, controlled, study to compare closed-loop control and open-loop control of propofol by using the Entropy and SPI guided closed-loop infusion system.

Monitoring of Adequacy of Anesthesia using Entropy and Surgical pleth index to guide total intravenous anesthesia is more effective to maintain depth of anesthesia compared with target controlled infusion with open systems, it is unclear what driver and variables to achieve this goal be more physiological; in the literature doesn´t exist studies showing that the closed-loop system for hypnotic is better than the controlled algorithm based pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain anesthetic depth. Thus, a system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based on neuromonitoring with Entropy and surgical pleth index as adequacy of Anesthesia depth.

The purpose of this study is to determine the therapeutic effectiveness of a closed loop TCI for administration of intravenous anesthesia using adequacy of anesthesia monitoring to maintain a depth of anesthesia compared to an open loop system TCI.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Scheduled for noncardiac surgery elective low-risk or intermediate risk. -Expected surgery time greater than 1 hour
* Procedure requiring general anesthesia
* Classification of the American Society of Anesthesiologists (ASA) as I,II, lll

Exclusion Criteria:

* Pregnant women
* Surgery scheduled urgent or emergency
* Personal history of allergy to eggs or any other part of propofol
* Personal history of abnormalities or congenital or acquired cognitive sequels: infantile cerebral palsy, Down syndrome, cerebral ischemic disease, traumatic brain injury, brain tumor, autism.
* Chronic use of benzodiazepines or antipsychotics
* A patient who does not consent to participate in the study prior to surgery or before randomization
* Need for anesthetic or analgesic blockade before surgery peripheral nerve
The Effects of Different Dialysate Calcium Concentration

The investigators enrolled 90 patients on maintenance hemodialysis with dialytic vintage ≥12 months, iPTH 150-300pg/ml and serum calcium\<2.5mmol/L. Patients were randomized to three groups with different dialysate calcium concentration , 1.25 mmol/L(DCa1.25), 1.5mmol/L(DCa1.5) and 1.75 mmol/L(DCa1.75) for 24 months respectively. Hemodialysis was performed for 4 hours three times weekly. Serum total calcium(tCa), ionized calcium(iCa),intact parathyroid hormone(iPTH)and phosphorus (P) levels were recorded before and after the study and single dialysis session in every patient. iCa and P levels were measured in spent dialysate.Bone density, bone-specific alkaline phosphatase(BAP), osteoprotegerin(OPG)、β-crosslaps、total Procollagen Type I Intact Propeptide (P1NP）and vascular calcification were measured in every patient periodically. vascular calcification including aortic arch calcification, abdominal aorta calcification and coronary artery calcification were measured by chest radiography, lateral lumbar radiographs and coronary artery computer tomography (CT) respectively. The primary endpoints included death, cardio-cerebral vascular disease(defined as heart failure, myocardial infarction and stroke), newly nontraumatic bone fracture, secondary parathyroidism uncontrolled by medicine and valvular or vascular calcification. The secondary endpoint were admission or emergency observation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65, maintenance hemodialysis, dialytic vintage ≥12 months, iPTH 150-300pg/ml, serum calcium\<2.5mmol/L, serum calcium\<2.5mmol/L.

Exclusion Criteria:

* Age\<18 or \>65 Severe acid-base disturbance History of parathyroid glands or adrenal gland combined with consumptions or malnutrition anemia due to acute bleeding or other diseases except for renal failure newly occurred bone fracture within 3 months active stage of immunological diseases using glucocorticoid or immunosuppressor combined with any disease with expect duration \<2 year newly occurred acute heart failure, acute myocardial failure , acute cerebral infarction or stroke within 6 months pregnant women of women in preparation for pregnancy
Expanded Access to Bimatoprost (Durysta)

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Durysta (Bimatoprost) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

* The participant must not be eligible for bimatoprost implant (Durysta) clinical trial.
* Eligibility for this program is limited to patients with moderate or worse glaucoma who are at risk of severe visual impairment based on physician assessment of risk factors associated with visual field progression as defined by the respective country/regional glaucoma clinical practice guidelines (eg, Canadian Ophthalmological Society guidelines, European Glaucoma Society guidelines, etc.), and who have exhausted all the appropriate pharmaceutical treatment options and are contraindicated for surgery, which may include:

  * Patients with ocular comorbidities such as severely scarred conjunctiva (eg, chemical burns, Stevens-Johnson Syndrome), scleral thinning.
  * Patients who are intolerant to any pre- , intra-, or post-op treatments (e.g allergy/intolerance to medical treatments or to anesthesia).
  * Patients with systemic comorbidities (e.g cardiovascular conditions) in which any surgery is not recommended
Endocrine Changes in Adults Undergoing Cardiac Surgery

In this prospective study the investigators want to measure the serum level changes of the thyroid hormones (thyroid-stimulating hormone, reverse triiodothyronine, serum free T4), brain natriuretic peptide (BNP), testosterone and sexual hormone binding protein (SHBG) in adults undergoing cardiac surgery and search for correlations different psychosocial factors and analyze the influence on the survival and the length of ICU/hospital stay.

In this study the investigators want to analyze routinely collected data of patients who underwent any kind of elective cardiac surgery in our university cardiovascular centre between 07.01.2018 and 30.06.2020. The database contains descriptive parameters, history of past illnesses, recent medication. The investigators record the type of surgery, the list of contributory physicians, the length of the surgery and the data of the anaesthesiological report. After the surgery the researchers want to record the postoperative parameters on the ICU ( infusion - fluid balance, blood transfusion, bleeding, main hemodynamic parameters, length of mechanical ventilation,main parameters of arterial blood gas analysis). Moreover th investigators want to collect psychosocial tests (Beck Depression Inventory, State Anxiety Scale, Trait Anxiety Scale and EQ-5D for the measurement of quality of life) to get more information from the postoperative condition of the patients.

Eligibility Criteria:
Inclusion Criteria:

* elective cardiac surgery

Exclusion Criteria:

* lack of consent
* pregnancy
* acute surgery
* exposition with iodin-containing contrast material
Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid Arthritis

The purpose of this study is to investigate the safety and tolerability of the new medication ASK8007, and to study whether it has a beneficial effect on joint inflammation in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* meet the American Rheumatism Association (ARA) 1987 revised criteria for the classification of RA (also referred to as the American College of Rheumatology \[ACR\] criteria);
* being treated with an adequate dose (to the discretion of the local physicians) of either MTX or leflunomide (LEF)or sulfasalazine (SS2) for at least 4 months prior to baseline of which the last 6 weeks before baseline were at a stable dose;
* have active poly-arthritis (i.e. active rheumatoid arthritis as defined in detail in the protocol)

Exclusion Criteria:

* have been treated with any registered or non-registered investigational drug in the context of a clinical intervention study during the last 3 months before baseline;
* have been treated with TNFα-blockers within a certain period of time (defined for each medication) before baseline;
* have been treated with any DMARD other than MTX, LEF or SS2 during the last month before baseline;
* documented evidence for the presence of clinically severe, unstable, or uncontrollable renal, hepatic, respiratory, hematological, genitourinary, cardiovascular, endocrine, neurological, psychiatric, or other medical illness which would, in the opinion of the investigator, put the patient at safety risk or mask measures of efficacy.
Nutritional Status in Children Treated With Advanced Nutrition Therapy

Background: There are few studies about nutrition to children and adolescents with cancer, and in particular during stem cell transplantation (SCT). Studies from other countries suggest that malnutrition is common on admission; the situation decline during treatment and may persist for a long time.

Aim: This project aims to improve the nutritional therapy to children being treated for cancer and children undergoing stem cell transplantation

Design, methodology and selection: The study consist of two parts: A retrospective study (registry study) of malnutrition among all children with cancer, admitted during a two year period, and a clinical trial to evaluate the effect of a standardized nutrition protocol for children undergoing SCT. Nutritional status is assessed before, during and one year after treatment with SCT.

The subjects are 140 children and adolescents (2-17 years) being treated for cancer and a subgroup of 25 patients treated with SCT at Oslo University. The results will be compared with a reference group of 25 patients treated with home parenteral nutrition as well as 50 healthy reference persons in the same age group.

The methods used for measurement of nutritional status are: Body composition, bone density, blood tests, diet record, activity detection and measurement of quality of life. The measurements are done on three occasions for patients with cancer and stem cell transplantation, and on one occasion with a reference. Information on demographics and medical care will be taken from journal. Growth data will be collected from health centres when needed. Parents' experiences of children's feeding problems will also be examined.

Eligibility Criteria:
Inclusion Criteria:

* All patients will be recruited from Oslo University Hospital. Inclusion criteria are age 2 -17 years of age. The SCT and HPN group will include children who have not previously undergone transplantation, who do not have a pacemaker or other implants that prevent the measurement of muscle mass. Participants in the reference groups will be of the same age group, without congenital syndromes or previous cancers.

Exclusion Criteria:

* Exclusion criteria are patients who reject bone marrow
SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY

The main aim of the study is to currently define the prevalence of celiac disease (CD) in children aged 5-10 years in 2 Italian cities (Ancona and Verona). The screening protocol is based on a 1st line genetic test (searche of HLA DQ2/DQ8 genotypes) followed by a serological diagnosis (IgA TTG and IgG DGP).

All scholar children aged 5-10 years living in the cities of Ancona and Verona will be invited to partecipate. Children enrolled will be investigated as follows:

1. HLA DQ2/DQ8 genotyping (by a rapid test)
2. In children genetically predisposed to CD serological investigations will be performed (both IgA TTG and IgG DGP antibodies)
3. The overall population will be evaluated for the prevalence and severity of dental caries (by using the DMFT/dmft index)

Eligibility Criteria:
Inclusion Criteria: age 5-10 -

Exclusion Criteria: celiac disease, on a gluten free diet

-
Phase 1 Clinical Trial of CordSTEM-ST

This clinical study will evaluate the safety and tolerability of CordSTEM-ST after administering a single dose in patients with premature ovarian insufficiency (POI), as well as identify the maximum tolerated dose (MTD) and evaluate the potential therapeutic effects.

3 or 6 subjects will be enrolled sequentially by applying the "traditional 3+3 design" to evaluate the dose limiting toxicities (DLTs) for 28 days from the first administration date of the investigational product according to the protocol. A DLT is defined as the occurrence of a grade 3 or higher adverse drug reaction (ADR) according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

First three subjects will be enrolled in Study Group 1 (low dose group) to be evaluated for DLTs up to 28 days after IP administration. If none of three subjects develope DLT, three subjects for Study Group 2 (high dose group) will be recruited. If one out of three subjects in Study Group 1 develop DLT, additional three subjects in Study Group 1 will be enrolled to be evaluated for DLT. If two or more subjects develop DLT in initial three subjects, the study will be terminated.

This study will be followed up by a long-term follow-up study under the separate protocol.

Eligibility Criteria:
Inclusion Criteria:

* Females aged ≥ 25 years and \< 40 years
* Individuals diagnosed with premature ovarian insufficiency: Individuals who have a follicle stimulating hormone (FSH) level of 40 IU/L or higher in the results of two tests conducted at least 4 weeks apart and are amenorrheic for at least 4 months
* Individuals who voluntarily decide to participate and provide written consent

Exclusion Criteria:

* Individuals diagnosed with primary amenorrhea\*

  \* No secondary sex characteristics by age 13, Absence of menarche for 5 years after initial breast development, or Absence of menstruation by age 15
* Individuals diagnosed with polycystic ovary syndrome
* Individuals with any other conditions that may affect the result of this study.