cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Whole Blood Transfusion for Trauma Brain Injury (TBI)

Our goal is to perform a pilot, single center study to evaluate the efficacy of whole blood (WB) in subjects with TBI, intracranial hemorrhage, and anemia compared to blood component therapy.

Both whole blood and blood components are given as standard-of-care based on the blood products available. If enrolled in this study, patients will be randomized 1:1 to receive either whole blood or blood components first. They will continue to receive blood products based on their assigned group. If they require more blood product than is available, they will cross over to the other group so they can continue to receive the transfusions needed for treatment.

The primary endpoint for this study would be improvement in coagulopathy pre and post intervention. Additionally, we will evaluate hemorrhagic progression of the intracranial bleed (HPIB), as measured by follow-up CT scan ordered over the first 24-hour post intervention (which is standard of care).

The secondary outcomes parameters would include intracranial pressure measurements (if performed), survival to discharge, safety and tolerability of Whole Blood administration in the TBI population, coagulation parameters and total blood product use, Glasgow Coma Scale (GCS) 24 hours post-injury, in-hospital mortality, and patient's discharge status (Glasgow Outcome Score Extended and disposition to home versus extended care facility).

Patients who decide to take part in the study, will have 26 mL of blood drawn (about 2 tablespoons) once before and once after blood transfusion for a total of 52 mL (about 4 tablespoons) of blood drawn, a CT scan at admission and at 24hour of blood transfusion, and information will be gathered from their medical record during their hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Age 15 years and older
* Head CT with presence of intracranial bleeding
* Required transfusion of whole blood (WB) or red blood cells (RBC)

Exclusion Criteria:

* Patients with non-survivable injuries (expected to die within 24-hours of injury)
* Fixed and dilated pupils
* Patients requiring a massive transfusion protocol activation
* Receipt of 2 units of WB or RBCs prior to enrollment
* Known prisoners
* Known pregnancy
Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

* Effects of autologous islet transplantation were compared to those of oral anti-diabetic drugs after distal pancreatectomy.
* The primary interest is a insulin-secretory function after the surgery in two intervention groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent distal pancreatectomy for pathologic diagnosis of pancreatic mass

Exclusion Criteria:

* Prior history of diabetes mellitus
* Patients whose fasting, post-load (75g OGTT) glucose or HbA1c level meet ADA diagnostic criteria
* Patients who refused to participate the study
Effect of Botox and Vibration on Bone in Children With Cerebral Palsy

Cerebral palsy (CP) is a neuromuscular disorder that affects approximately 800,000 individuals in the U.S. An estimated 70-80% of these individuals have spasticity which affects ambulation and requires management. Therefore, the treatment of spasticity is a primary goal of interventions for children with CP. One treatment widely used to reduce spasticity is Botox because of its ability to temporarily paralyze a muscle. However, no studies have determined the effect of Botox treatment on bone in humans. Also, a low magnitude vibration treatment has been shown to improve bone structure in the lower extremity bones of children with CP. The aims of this study are: 1) to determine the effect of Botox treatment in conjunction with a daily vibration treatment on bone mass and bone structure in children with spastic CP, and 2) to identify the mechanism that underlies the effect of Botox and vibration on bone.

The investigators have been working with children diagnosed with cerebral palsy (CP) for the past 10 years. The investigators have found that bone structure is markedly underdeveloped and bone strength is severely compromised in children with CP. Also, an increased fracture rate has been observed in the lower extremity bones of children with CP. There is evidence that Botox, which is used to treat spasticity in CP, can improve motor function; however the effect of Botox on human bone is unknown. There is also evidence that low magnitude vibration treatment can improve bone mass and bone structure. The overall goal of this current research study is to investigate the effect and mechanism of action of Botox and vibration on bone in children with CP. The investigators will also examine the effect of Botox on muscle volume.

A total of 36 participants will participate in this study. The investigators will assess bone structure and muscle volume using MRI. The investigators will assess bone mass using dual-energy X-ray absorptiometry (DXA).

Eligibility Criteria:
Inclusion (Children with CP):

1. Have spastic CP
2. Between 2-12 years of age
3. Recommended for Botox treatment by their physician as part of their clinical care. Those who accept Botox treatment and those who do not accept Botox treatment are both eligible for the study.
4. A score of 1-4 on the gross motor function classification scale (GMFCS)

Exclusion (Children with CP):

1. Botox treatment in the lower extremities within the last year
2. Metal rods in both legs

Inclusion (Typically developing children):

1. Between 2 and 12 years of age.
2. Match a child with CP for sex, age and race.

Exclusion(Typically developing children):

1. Neurological disorder
2. Surgery in the lower extremities within the last year.
3. Chronic medication use
A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid leukemia (CML) once daily (QD) or twice daily. (BID)


Eligibility Criteria:
Inclusion Criteria:

* Philadelphia chromosome positive or bcr-abl gene positive Chronic phase Chronic Myelogenous Leukemia (CML) subjects must have primary or acquired resistance to Imatinib mesylate or have intolerance of imatinib mesylate
* Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
* Men and women, ages 20 to 75
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized

Exclusion Criteria:

* Subjects who are eligible and willing to undergo transplantation at pre-study
* Women who are pregnant or breastfeeding
* Uncontrolled or significant cardiovascular disease
* History of significant bleeding disorder unrelated to CML
* Adequate hepatic function
* Adequate renal function
* Medication that increases bleeding risk
* Medication that changes heart rhythms
* Subjects who are compulsory detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Fetal Alcohol Spectrum Disorder : Clinical Description and Search for Epigenetic Biomarker (EPI-TSAF)

The goal of this clinical trial is to carry out a clinical description of a Reunionese series of patients (aged 0 to 18 inclusive) with Fetal Alcohol Spectrum Disorders followed up in the Genetics Department of the University Hospital in Reunion Island The aim is also to identify a specific "epigenetic signature" for Fetal Alcohol Spectrum Disorder, in order to provide early diagnostic markers, determine the origin of the microRNAs identified and study the phenotypic-epigenetic relationship (microRNAs).

This research is descriptive and monocentric.

* retrospective on the clinical description of 182 Fetal Alcohol Spectrum Disorderpatients
* prospective on the microRNAs part, with 18 patients in the Fetal Alcohol Spectrum Disorder group and 18 in the control group (participants without Fetal Alcohol Spectrum Disorder).

For the 18 patients in the Fetal Alcohol Spectrum Disorder group, the doctor will take a blood sample (for genetic testing) during a scheduled consultation. A remaining 4 ml of blood will be collected for research purposes (Fetal Alcohol Spectrum Disorder group only). A buccal smear will also be taken for research.

For the 18 participants in the control group (healthy participants of the same age and sex as the Fetal Alcohol Spectrum Disorder group), only a buccal smear will be taken for research purposes during a consultation.


Eligibility Criteria:
Inclusion Criteria:

Fetal Alcohol Spectrum Disorder group :

* born in Reunion
* aged between 0 and 18 years old
* Having been exposed to alcohol during the prenatal period
* Have a diagnosis of Fetal Alcohol Spectrum Disorder by a referring physician

Control group :

* born in Réunion
* aged between 0 and 18 years old
* Be matched on the age and sex of the Fetal Alcohol Spectrum Disorder children sampled (n=18)
* Not having been exposed to alcohol during the prenatal period
* Not having been diagnosed with FASD
* Not have congenital malformations
* Not have neurodevelopmental disorders

Exclusion Criteria:

Fetal Alcohol Spectrum Disorder group :

* patients with Fetal Alcohol Spectrum Disorder who also present another genetic syndrome.

Control group :

- people who are not matched on the age and sex of the Fetal Alcohol Spectrum Disorder patients sampled
Onduo Virtual Diabetes Clinic Study

This is a prospective, single arm study designed to evaluate the change in hemoglobin A1c after 4 months of participation in the Onduo Virtual Diabetes Clinic (VDC) in individuals with Type 2 diabetes and suboptimal glycemic control.

The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services accessed via a software application (Onduo App).

Eligible subjects are asked to use the Onduo App and commercially available FDA-regulated medical devices and non-medical devices, for up to 4 months.

Subjects receive a continuous glucose monitor (CGM) and are asked to use the device for up to 6 wear cycles of 10 days each.

Subjects are scheduled for a medical review via a face-to-face telemedicine consultation with a VDC Physician.

Subjects may have their diabetes medications changed by a VDC Physician following their telemedicine visit.

Information provided to a subject in the course of the study is not intended as a substitute for the subject's primary care provider's guidance.

At the completion of the subject's study participation, the Onduo App will be deactivated and there will be no further data collection through the app.

A1c levels and surveys are collected at 1 year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female; 18 years of age or older
* Confirmed diagnosis of Type 2 diabetes mellitus
* Willing to use CGM and BGM
* A1c result ≥8.0% and ≤12.0%
* Receive their diabetes care from Premier Medical Associates or the Palo Alto Medical Foundation
* Own a Smartphone with a data plan and be the primary user of that smartphone
* Smartphone must use a supported Android OS or iOS

Exclusion Criteria:

* Pregnant or breastfeeding
* Use of an insulin pump
* Any condition or situation that the Sponsor or Investigator determines as inappropriate for study inclusion
Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)

This is an independent optional sub-study parallel to TB-018 (NCT01755598) in which biological samples will be collected for future investigations on biological correlates, markers or prognostic factors for TB disease. Subjects who consent to enroll in TB-018, "A phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate tuberculosis (TB) vaccine GSK 692342 (M72/AS01E) against TB disease, in healthy adults aged 18-50 years, living in a TB endemic region", (see NCT 01755598) will be asked to participate in this sub-study. Subjects enrolled in TB-018 who also consent to C-041-972 will be followed according to the TB-018 protocol but will have additional blood samples collected for the sub-study.

Additional information in the protocol

Eligibility Criteria:
Inclusion Criteria:

To be eligible for this sub-study, subjects must be enrolled in TB-018 and provide separate written informed consent for C-041-972. See NCT 01755598 for inclusion criteria into TB-018.

Exclusion criteria:

To be eligible for this sub-study, subjects must be enrolled in TB-018 and provide separate written informed consent for C-041-972. See NCT 01755598 for exclusion criteria into TB-018.
ALknee Follow-up Study of the Cementless ATTUNE Rotating Platform and the Cementless LCS Rotating Platform Knee System

The cementless ATTUNETM Rotating Platform Knee system was compared in a single-blind, randomized RSA trial to its predecessor, the LCS rotating platform Knee System. In this previous study, 61 knees were subjected to RSA examinations at 1-day and 3, 6, 12 and 24 months postoperative. This study found a promising equal migration of both tibial components and a lesser migration of the femoral component of the ATTUNETM knee system after two years, although with a similar migration rate between year 1 and 2. this raises the question of whether the migration of the prostheses relative to each other will increase or remain the same in the long term. To examine this, a mid-and long-term RSA follow-up to measure migration is necessary. In addition, another new RSA measurement parameter has become known in recent years that may provide an indication of the bonding of the prosthesis to the bone at the time of measurement. This new parameter, called the Induced Displacement (ID) of a prosthesis, measures the position and orientation relative to the bone while the prosthesis is under different loading conditions (e.g., patient in supine or standing position). This means that a large measured difference between these different loading condition measurements would indicate that osseointegration of the prosthesis never occurred or is no longer present. To improve the understanding of the tendency of both prostheses to aseptic loosening after a mid- to long-term follow up, migration over time and inducible displacement analyses are necessary.

The primary objective of this study is to accurately compare mid- and long-term migration of two uncemented TKR prostheses. The secondary objectives of this study are to evaluate if inducible displacement can be used as a parameter to detect loose implants, and to compare inducible displacement, clinical and radiological outcome and patient-reported outcomes (PROMS) after a follow-up of 5 and 10 years of two uncemented TKR prostheses.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* The Patient participated in the initial study (NL58911.058.16) \[1\].
* The patient is capable of giving informed consent and expressing a willingness to comply with the study.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* The patient underwent a major revision TKR (exchange of the tibial or femoral component).
* The patient is unable or unwilling to sign the informed consent specific to this study.
Quality of Erection Study

The study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).


Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged 18-55
* Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)

Exclusion Criteria:

* Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction \[Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening\]
US Guided Axillary Block With Only One Injection

The investigators conducted this prospective, randomized, observer-blinded, non-inferiority trial to compare single perivascular injection to double injection (musculocutaneous nerve and perivascular injection) US guided axillary brachial plexus block.

The investigators have been challenged by the question of whether all a single injection may be enough to successfully perform a axillary plexus block.

Three hundred and twenty patients undergoing elective hand surgery under axillary brachial plexus block will be enrolled into this prospective, randomized, observer-blinded non inferiority trial. Using a computer-generated sequence of random numbers and sealed envelope technique, the patients included will randomly be allocated to receive either single or double injection ultrasound-guided axillary block. The block will be performed with the in-plane technique using a 22 gauge, 50 mm needle and a high frequency linear probe.

In the 2 injection group, the needle will initially be advanced toward musculocutaneous nerve and 7 ml of LA (lidocaine 1.5% with epinephrine 5µg/ml) will be deposited around the nerve. The needle will be then advanced until the tip will be positioned just dorsal to the artery and 28 ml of (lidocaine 1.5% with epinephrine 5µg/ml) will be deposited in this location. In the single injection group using the same LA, and 35 ml will be deposited dorsal the artery.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 year of age, ASA physical status I-III, BMI 25 to 35 Kg/m2

Exclusion Criteria:

* non consents patients, any contraindication to brachial plexus anesthesia (local anesthetic allergy, local infection and coagulopathy), preexisting neuropathy, hepatic or renal failure, pregnancy and surgery in the axillary region.
Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies.

This study is being done to see if there are any long term health related issues in women with APA and recurrent miscarriages.

The association between APA and thrombosis is well documented. Both LA and ACA are often detected in individuals with SLE but there is no prospective data on the risk of thrombosis in women who present with recurrent miscarriages in association with APA. This study should significantly advance medical knowledge of the natural history of primary antiphospholipid syndrome (PAPS) which is essential to enable optimal management of relatively young women who may be at risk of complications, some of which are potentially life threatening.

Eligibility Criteria:
Inclusion Criteria:

Antiphospholipid syndrome History of recurrent miscarriages

Exclusion Criteria:

Previous thromboembolic disease
Study of Rifaximin in Minimal Hepatic Encephalopathy

Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome and metabolome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* cirrhosis diagnosed by clinical or biopsy grounds
* Minimal hepatic encephalopathy defined by impaired performance on at least 2 of the following: number connection tests A/B, digit symbol and block design tests (NCT-A, NCT-B, DST and BDT) compared to age and education-matched controls.
* No contraindications to MRI
* TIPS (transjugular intra-hepatic porto-systemic shunt) procedure or elective surgery planned within the next 8 weeks

Exclusion Criteria:

* Current therapy with lactulose, rifaximin or other treatment for hepatic encephalopathy.
* Prior episodes of overt HE
* MMSE \<25
* TIPS placement
* Unable to give informed consent.
* Contra-indications to MRI
A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight

This research study tests if CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight. Participant will either get CagriSema (active medicine) or placebo (a dummy medicine), which has no effect on the body. The treatment participants get is decided by chance. The study will last for about 32 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Aged 18-65 years (both inclusive) at the time of signing informed consent.
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* Body mass index (BMI) equal to or above 27.0 kilograms per meter square (kg/m\^2) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

* Glycated haemoglobin (HbA1C) greater than or equal to (≥) 6.5 % (48 millimoles per mole \[mmol/mol\]) at screening.
* History of type 1 or type 2 diabetes mellitus.
* Any clinically significant body weight change (≥5% self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.