cyrilzakka/clinical-trials huggingface dataset:
Heart and Renal Failure in Hip Fracture Surgery

Patients with acute hip fractures are old and vulnerable. With a majoriry classified as being ASA 3 or more. Frequently they receive spinal anesthesia perioperatively inducing hypotension. Even a short hypotensive period may induce postop cardiac T roponinT leakage as well as renal failure noted by Changes in Serum Creatinin or Cýstatin C This will be investigated and correlated to intraoperative hypotension as step one. Preliminary this will be followed by an intervention with vasopressor treatment perioperatively to preserve an adequte MABP

Patients with acute hip fractures are old and vulnerable. With a majoriry classified as being ASA 3 or more. Frequently they receive spinal anesthesia perioperatively inducing hypotension. Even a short hypotensive period may induce postop cardiac T roponinT leakage as awell as renal failure noted by Changes in S Creatinin or Cýstatin C This will be investigated and correlated to intraoperative hypotension as a step one. Preliminary this will be followed by an intervention with vasopressor treatment perioperatively to preserve an adequte MABP

Eligibility Criteria:
Inclusion Criteria:

* Hip fracture patient to be operated upon Classified as being ASA 3 or more

Exclusion Criteria:

* Not forfilling inclusion Criterias
Laparoscopic Assisted Doderlin Vaginal Hysterectomy

This prospective randomized clinical trial will be conducted in Ain Shams University Maternity Hospital during the period from May 2017 to December 2017. Group Ι: 30 patients will undergo conventional laparoscopic assisted vaginal hysterectomy (LAVH). Group ΙΙ: 30 patients will undergo laparoscopic assisted Doderlein vaginal hysterectomy (LADH)


Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 years.
* Uterine size ≤ 14weeks.
* Benign uterine pathology (Fibroid uterus, endometrial hyperplasia, DUB, uterine prolapse).
* No contraindication for laparoscopic surgery.

Exclusion Criteria:

* Gynecologic malignancy.
* Contraindications to laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
* Large abdominal hernia
* Large ovarian mass
* History of previous laparotomy finding extensive adhesions
Pharmacokinetic Study of a Single Dose of AVI-4126 (RESTEN-NG®) in Cerebral Spinal Fluid

Because AVI-4020 Injection was found to cross the blood-brain barrier, and because AVI-4126 (RESTEN-NG) has potential medical benefit to people with a variety of diseases, including cancers, this study is being performed to find out if AVI-4126 also crosses the blood-brain barrier. If it does, then additional investigations could be performed, such as in people with certain types of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult males 18 years to 64 years of age;
* Good general health (as evidenced by no chronic conditions, normal physical exam, vital signs within normal limits; laboratory evaluations within normal range)
* Signed and dated written informed consent form; and
* Willing to participate in all study activities and all requirements, including effective contraception (viz., a double-barrier method) during the 7-day study surveillance period.

Exclusion Criteria:

* Hematology, serum chemistry (exclusive of electrolytes), and urinalysis laboratory test values \>2 times upper limits of normal or anemia (hemoglobulin \<11 g/dL), leukopenia (total white blood count \<3,000/µL or total neutrophils \<1,500/ µL) or thrombocytopenia (platelets \<100,000/µL). Electrolytes and coagulation values exceeding normal ranges are to be excluded.
* Body Mass Index (BMI) \>35.
* Calculated creatinine clearance (by the Cockroft and Gault Formula) \<70 mL/min, based on age and gender.
* Positive HIV-1 or HIV-2 serology.
* Positive HCV serology and/or positive plasma HCV-RNA status.
* Positive HBsAg or HBcAb status.
* Solid or hematopoetic organ transplant recipient.
* Active illness or recent illness within 30 days of the first dose of study drug.
* History of any of the following: brain injury, neoplasm, chronic or migraine headaches, cancer, meningitis or hydrocephalus.
* Usage of any prescribed, over-the-counter or illicit drug(s) within 30 days of study drug administration. Use of herbal remedies and/or supplements at the discretion of the Investigator.
* Unwilling to practice effective contraception during the study period.
* Participation in any clinical interventional trial within the previous 6 months.
* Positive drug urine screen.
CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)

In general, the European pathological examination method primarily relies on pathologists and does not require the involvement of surgeons. The Japanese pathological evaluation approach, on the other hand, involves the intervention of surgeons, particularly in the extraction of lymph nodes from fresh specimens and the assessment of specimen quality. Given that the Japanese pathological assessment method lacks systematic evaluation and there is currently no literature clearly demonstrating its diagnostic accuracy, the main objective of this study is to verify whether the diagnostic accuracy of the Japanese pathological investigation method is inferior to that of the European pathological evaluation method.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with colon cancer who underwent colectomy;
* Patients with pathological confirmed adenocarcinoma;
* Patients agreed to participate in the study.

Exclusion Criteria:

* Patients suffered from rectal cancer;
* Patients diagnosed with colon cancer but did not undergo colectomy;
* Patients refused participation.
Gluten-free Diet Monitoring in Urine

The purpose of this study is to develope a novel method to determine gluten intake and to check gluten-free diet adherence in celiac patients by detection of gluten immunogenic peptides in urine.

To date, the mainstay of the management of CD is a strict life-long adherence to gluten-free diet (GFD). Follow-up monitoring of the improvement of patients on GFD is essential to assess symptomatic recovery and to monitor complications, as well as to assist patients with dietary compliance. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available.

In this study, we have overcome these challenges and shown the feasibility of measuring gluten immunogenic peptides (GIP) in urine samples in healthy and celiac individuals by solid phase extraction and estimating the peptide concentrations with a reader of anti-GIP moAb immunochromatographic strips (IC-strips).

Eligibility Criteria:
Inclusion Criteria:

* Celiac patient: childs (\< 16 years) and adults (\> 16 years)
* written informed consent

Exclusion Criteria:

* presence of family history of CD
* digestive disease symptoms
* known medical disease
* use of prescription medications and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study
* participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study
Measurement of Stress During Anesthesia With "Pain Detector" on Patients Receiving Atropine

24 patients randomly divided into two groups, one of the groups receiving atropine in addition to the planned anaesthesia. Skin conductance parameters to be compared between the two groups.

Skin conductance (SC), in terms of numbers of skin conduction fluctuations (NSCF), amplitude and mean skin conductance level, reflect the activity in the sympathetic postganglionic cholinergic fibers which innervate the palmar and plantar sweat glands. Skin conductance, especially numbers of skin conductance fluctuations, may be a promising tool to monitor anesthesia. Atropine, an anticholinergic agent, acts as an antagonist on the muscarinic receptors of the sweat glands and inhibits their secretion in a dose-dependent way. The aim of this study was to find out to what degree SC is influenced by i.v. administration of atropine.

Study hypothesis: SC is not influenced by i.v. administration of atropine.

Eligibility Criteria:
Inclusion Criteria:

* Patients in ASA-group 1-2
* Operations (anal fissures, anal fistulas and haemorrhoids) lasting for less than one hour
* informed consent
* BMI \<30

Exclusion Criteria:

* Patients using any medication known to influence the autonomous nervous system
* Patients with contraindications to atropine (e.i. fibrillation, glaucoma ect)
* BMI \>30
* Pregnancy
ALT-801 DDI Study in Healthy Volunteers

This is a Phase 1, open-label, drug-drug interaction (DDI) study of ALT-801 under steady state conditions on concomitantly administered medications in healthy subjects. The study will evaluate the effect of ALT-801 on the pharmacokinetics (PK) of metformin, warfarin, atorvastatin, digoxin, and the combined oral contraceptive (OC) ethinylestradiol/levonorgestrel. The study will be conducted in 3 parts, as described below. Each part will have 2 periods in a fixed sequence, where the first period is without ALT-801 administration and the second is with ALT-801 at steady state.


Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy volunteers, age 18 to 55 years, inclusive
* Body mass index (BMI) 25.0- 40.0 kg/m2
* Able and willing to provide written informed consent prior to entry into the study

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5%
* History of pancreatitis or hypersensitivity reaction to GLP-1 analogues
Effect of Raltegravir in Patients With Acute Tropical Spastic Paraparesis - Human T-Lymphotropic Virus 1 Infection

This is a pilot study of intervention in a group of patients with tropical spastic paraparesis/ myelopathy to evaluate virologic and clinical response of raltegravir plus zidovudine in this group of patients.

The study will the investigators develop in The Tropical Medicine Institute Alexander von Humboldt that is a referral center in Peru for diseases associated to Human T-Lymphotropic Virus 1 Infection (HTLV-1). The Institute has a cohort of around 600 patients currently being followed up and around 20 to 25 new patients are admitted every year with this disease.

This is a pilot study of intervention in a group of patients with tropical spastic paraparesis/ myelopathy to evaluate virologic and clinical response of raltegravir plus zidovudine in this group of patients on the follow-up of 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* human t lymphotrophic virus 1 confirmed
* Tropical Spastic Paraparesis of recent onset (less than 4 years)

Exclusion Criteria:

* Pregnant or breastfeeding or unwilling to use contraception.
* Treatment with immunosuppressive, immunomodulatory or experimental treatments within the last 6 months of enrolment in the study.
* Patients presenting with medical disorder such as poorly controlled diabetes or arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, abnormal liver function tests (\>2.5 times upper limit normal (ULN)) and abnormal complete blood count (in particular leukopenia, as defined by a lymphocyte count \<500, neutrophil \<1.5 or platelet count \< 100, or thrombocytopenia \< 1.5 low limit normal (LLN), or any medical condition which, in the opinion of the chief investigator, would pose additional risk to the patient.
* Presence of human immunodeficiency virus antibodies.
* Patients with active hepatitis B or/and C with liver function tests \>2.5 times ULN
* Exposure to any other investigational drug within 30 days of enrolment in the study.
The Efficacy of Speech Competition Training on Auditory Hallucination in Schizophrenia

One hundred schizophrenia patients with auditory hallucinations will be recruited and randomized into group A and group B. Participants of group A will firstly receive a speech competition training for 2 weeks, and those in group B will firstly receive music intervention as placebo treatment. Specifically, speech competition training include voice competition training twice a day in adjunction with drug treatment, and the patients will be required to perform voice-related tasks according to the instruction. The reaction time, accuracy rate and the number of auditory hallucinations during the task will be recorded. On the other hand, the placebo treatment includes soothing music twice a day for a fixed period of time while patients receiving drug treatment. After 2 weeks, the interventions for group A and group B will be switch.

Clinical symptoms will be evaluated using the auditory hallucinations rating scale, positive and negative syndrome scale, belief about voices questionnaire-revised at baseline, 2-week follow up and 4-week follow up. All the data will be analyzed with the Statistical Product and Service Solutions(SPSS) software.


Eligibility Criteria:
Inclusion Criteria:

* Fulfilling the diagnostic criteria for schizophrenia as in the International Classification of Diseases (ICD) - 10;
* Aged 18-55 years old;
* Education level over 6 years;
* The score of P3 item in PANSS ≥ 3 points;
* Taking antipsychotics at a therapeutic dose for at least 1 month, and the symptoms of auditory hallucinations have not been significantly improved, and the score of Auditory Hallucinations Rating Scale (AHRS) is still greater than 18 points;
* Capable of understanding and singing a written informed consent form, and be able to cooperate in completing intervention training and assessments.

Exclusion Criteria:

* Diagnosing other Axis I mental disorders;
* A history of severe neurological disease, brain trauma, major physical disease or history of drug dependence;
* Auditory hallucinations caused by organic brain diseases;
* Patients who cannot cooperate with the completion of training;
* Patients with serious suicidal or self injurious behavior;
* Pregnant and lactating women;
* History of alcohol abuse;
* Intellectual impairment (IQ\<70);
* Patients with hearing impairment.
Assessing Contacts' Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation

This study aims to establish an effective method to inform parents or close relatives of newborns about the risk of pertussis transmission to newborns and the advantages offered by the cocooning strategy (vaccinating those who are in close contact with the newborn) by assessing the factors that affect the parents' decision-making to accept pertussis immunisation.

Two phases are foreseen in the study. The 'questionnaire design' phase will be conducted in order to finalise the electronic questionnaire. The enrollment phase will involve the administration of the final web-based questionnaires to the subjects included in the enrollment phase.

The data generated in this study will be useful to inform parents of newborns about the advantages of vaccinating people who are in close contact with the newborn even before the baby is born in order to prevent the transmission of pertussis to the newborn.

No vaccine will be administered during this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that, can and will comply with the requirements of this protocol (ability to understand the study objectives and the questions asked, and ability to operate a computer).
* Written informed consent obtained from the subject.
* Subjects aged ≥ 18 years at the time of study start who are either:

Contacts of newborns (aged ≤ 6 months). OR Expecting mothers in their last trimester of pregnancy or their partners, who will be in close contact with the newborn.

• Subjects who will be eligible for pertussis booster vaccination and have not received any pertussis vaccination in the last 2 years (before study start).

Exclusion Criteria:

* Subjects who have participated in the 'questionnaire design' phase (applicable only for subjects who will participate in the enrollment phase of the study).
* Subjects with a contraindication to pertussis vaccination.
* Subjects who declare to be in principle against vaccination.
* Subjects who declare to be in a chronic physical condition and not compatible with vaccination.
* Subjects with a history of pertussis in the last 5 years (before study start).
* History of non-response to pertussis vaccination.
* Subjects with mental deficiency.
* Subjects with unstable chronic health condition(s).
Harnessing Neuroplasticity to Enhance Functional Recovery During Chronic Recovery From Upper Extremity Nerve Repair

This study adopts a strategy that has arisen from basic neuroscience research on facilitating adaptive brain plasticity and applies this to rehabilitation to improve functional recovery in peripheral nervous system injuries (including hand transplantation, hand replantation, and surgically repaired upper extremity nerve injuries). The technique involves combining behavioral training with transcranial direct current stimulation (tDCS)-a non-invasive form of brain stimulation capable of facilitating adaptive changes in brain organization.

This study will implement and evaluate an innovative program of post hand transplant rehabilitation; one that harnesses recent discoveries in neuroscience to facilitate long-term, experience-dependent adaptations within the brain's sensory and motor systems. The current approach to rehabilitation of function in allogeneic hand transplant recipients is largely the same as standard-of-care following hand replantation (re-attachment) and peripheral nerve repairs. This involves an eclectic combination of traditional therapies. In seeking to improve on this approach, there is potentially much to be gained by considering evidence that limb amputation not only impacts the peripheral nervous system but also the brain, and tailoring interventions accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Individuals whom have received a unilateral allogeneic transplantation proximal to the wrist and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).
* Individuals whom have undergone a complete amputation the hand between the wrist and elbow followed by successful re-attachment and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).
* Individuals whom have undergone repairs of the median, ulnar, or other related or nearby nerve(s) following complex volar forearm lacerations or other injuries between the distal wrist crease and the flexor musculotendinous junctions. Individuals must be at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).

Exclusion Criteria:

* Individuals with significant/severe brain trauma
* Serious psychiatric conditions
* Chronic or severe neurological conditions.
* Current pregnancy
* History of seizures or unexplained loss of consciousness
* Metallic implants above the chest
* Certain implanted medical devices.
Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses

This is a randomized prospective clinical study comparing the Acquire Biopsy Device to SharkCore Biopsy Device.

At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using one of the two FNB needle. All patients will undergo sampling of pancreatic masses using both needles but the needle to be used first will be based on randomization. Subsequent passes will be performed by alternate needles and once onsite diagnosis is established using either needle type, more passes will not be performed for onsite diagnostic adequacy. However, a minimum of at least one pass and a maximum of 8 passes will be performed using both needle types. The number of passes needed to achieve diagnostic adequacy using both needles will documented.

Four dedicated passes will then be performed using the initial randomization sequence for cell block. Two passes will be performed using each needle type and the specimen will be preserved in formalin and sent for cell block processing.

If the doctor cannot obtain enough tissue with the study needles, another needle with a different gauge (19 or 25) will be used. This will also be a maximum of 8 passes. Information about the number of needles used, how many passes were performed, any problems with the needles will be collected. If there is not enough tissue available from these passes to establish a diagnosis, the subject will be asked to come back at another time for a repeat procedure.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo EUS
* Patients with solid pancreatic masses on cross-sectional imaging or with jaundice secondary to biliary obstruction
* Able and willing to provide written or verbal consent

Exclusion Criteria:

* Unable to safely undergo EUS for any reason
* Coagulopathy (Prothrombin time \> 18 secs, platelet count \< 80,000/ml)
* Active alcohol or other drug use or significant psychiatric illness
* Pregnancy
* Unable or unwilling to provide consent
Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea

The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.

This is a prospective randomized, double-blind, placebo controlled, parallel group, Phase 2 study. Subjects meeting selection criteria will be randomly assigned to receive 12 weeks twice daily (BID) dosing with FK614 or placebo. Enrollment for this study will be approximately 200 patients.

Eligibility Criteria:
Inclusion Criteria

* Has history of type 2 diabetes mellitus for at least 1 year
* Has been taking current sulfonylurea (SU) for at least 3 months. Subjects currently taking metformin may be eligible to be switched.
* Has not received any oral antidiabetic medication other than an SU or taken regularly prescribed insulin for at least 3 months

Exclusion Criteria

* Has type 1 diabetes mellitus
* Has uncontrolled hypertension, i.e., systolic BP \>170 or diastolic BP \> 95 mm Hg.
* History of congestive heart failure
Tumor: Breast Ratio Study

This is an observational study of 3 arms: breast conservation therapy, mastectomy and reconstruction, and mastectomy only.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be scheduled to undergo breast conservation therapy (BCT), mastectomy or mastectomy with immediate reconstruction (defined as initiating the reconstructive process at time of mastectomy) for ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), and early stage breast cancer (Clinical Stages IA-IIB). Stage IIB tumors are 2-5 cm with micrometastases 0.2 to 2.0 cm in lymph nodes; or 2-5 cm tumor with 1-3 positive axillary or internal mammary lymph nodes, or \>5 cm with no lymph node involvement. Clinical staging, based on imaging and physical exam will be used for enrollment. Patients that are upstaged due to unexpected findings at the time of surgery/assessment of surgical pathology will be excluded at that time. For staging reference please see http://www.cancer.gov/cancertopics/pdq/treatment/breast/patient/page2#keypoint13
* If multifocal/multicentric disease of the ipsilateral breast is encountered and patients are still deemed eligible for BCT or mastectomy per standard of care, then the tumor area will be calculated as the total volumes of the identified foci.
* Patient must be between 18-72 years old
* Patient must be able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* Cognitive impairment
* History of radiation to the chest wall or breasts
* Patients unable to undergo MRI due to metallic implant or claustrophobia
* Patients that are pregnant since breast MRI is contraindicated
* History of previous breast surgery other than primary cosmetic augmentation or breast reduction
* Identification of a concurrent or synchronous contralateral cancer during the enrollment period
* Any patient that would not have been considered for BCT or reconstruction
* BCT patients planning to proceed with reconstruction during their study participation timeline