cyrilzakka/clinical-trials huggingface dataset:
An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml

To provide product through an expanded access program to HIV-infected patients with CD4 counts less than 300 cells/ml.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* CD4 counts \< 300 cells/ml.

NOTE:

* If a patient's CD4 count is 275 to 300 cells/ml, the patient must either rescreen for Study 806 or wait 6 months before entering the expanded access program.
* Patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies.
* Patient must not meet inclusion criteria for other Remune trials.
* Patient must have laboratory tests within specified limits.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Clinically significant cardiac, hepatic, renal, or gastrointestinal dysfunction.
* Current participation in a Remune study.

Concurrent Medication:

Excluded:

* Use of any immune-modulating drugs.
* Induction therapy or initiation of new treatment regimen for an AIDS-defining condition.

Patients with any of the following prior conditions are excluded:

Previous participation in a Remune study.

Prior Medication:

Excluded:

* Use of any immune-modulating drugs within 3 months of Day 1 visit.
* Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 visit.
A Study in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays

GSK Biologicals is working on the development of a vaccine to protect elderly people from bacterial pneumonia. Diagnostic of bacterial pneumonia is difficult, and for the future studies in that project, it would be useful to have some easy non invasive tests. New clinical read-outs are needed to detect and identify the causative pathogen. These assays will be based on specific antigen detection in the urine or specific pathogen DNA detection in the blood. Technical and clinical validation of these assays will be realised at later stage with samples coming from epidemiological and/or phase III studies.

To allow the development of such tests in GSK Biologicals laboratories, urine and blood samples are needed from subjects aged 65 or above who have diagnosed pneumonia.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female aged 65 or above at the time of the study.
* Written informed consent obtained from the subject.
* Clinical pneumonia diagnosed by chest X-ray detected within 7 days before study entry.

Exclusion Criteria:

* Vaccination with a pneumococcal or Haemophilus vaccine within the last 3 months before study entry.
* Antibiotherapy started more than 7 days before Screening.
* A negative culture for Streptococcus pneumoniae or Non-Typable Haemophilus influenza.
* A urine sample at Screening less than 40 mL.
A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women

A study to measure daridorexant in breast milk of healthy lactating women


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Healthy lactating female subject aged at least 18 years at Screening.
* Female subject who has delivered a term infant (≥ 37 weeks' gestation) and who is breastfeeding her infant (and/or pumping) for at least 2 weeks postpartum at Screening; lactation must be well-established to maintain an adequate milk supply with regular breastfeeding (and/or pumping, e.g., 3 to 4 times per day and not providing more than 1 supplemental bottle of formula per day and the infant has not started eating solids). Subjects planning on weaning their infants after enrollment who meet the afore mentioned requirements will be considered for enrollment in the study.
* Agreement to refrain from breastfeeding any infant with her own milk from Day -1 up to 72 h after study treatment administration.
* Ability of subject's infant to feed from a bottle or no anticipated compromise of subject's infant's nutrition with time period of refraining from breastfeeding planned during the study.
* Agreement to collect breast milk from pre-dose (directly prior to study treatment administration) to Day 4 (72 h after study treatment administration) using an electric pump provided by the study site.
* Must agree to use an acceptable effective method of contraception consistently and correctly (e.g., oral progestin-only contraceptive; implants; intra uterine devices; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide) from Screening up to at least 72 h after study treatment administration, be sexually inactive, or be in same-sex relationship.

Exclusion Criteria:

* Known hypersensitivity to daridorexant or treatments of the same class, or any of its excipients.
* History of narcolepsy.
* Mastitis or other condition that prevents the collection of breast milk from one or both breasts at Screening or on Day -1.
* History of breast implants, breast augmentation, or breast reduction surgery which prevents the collection of breast milk.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Caudal Block Versus Ultrasound Guided Ilioinguinal/Iliohypogastric Block in Pediatric Patient

The caudal block is the most common technique for inguinal surgery. Increased use of ultrasound in regional analgesia techniques has been improved the practise of the peripheral nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative methods to the central blocks. The aim of this study is to compare analgesic efficiency of caudal block and ultrasound guided Ilioinguinal and iliohypogastric nerve blocks for bilateral inguinal hernia in pediatric patients

In this prospective randomized study, pediatric patients between 1- 10 years old who were scheduled to bilateral inguinal hernia surgery wil be enrolled the study. The patients wil randomly assign to receive an ultrasound-guided Ilioinguinal/iliohypogastric block group or caudal block group Ilioinguinal/iliohypogastric block was performed with 2 mg/kg bupivacaine as 0.25 % and total volum wil be divided equally for each side, Caudal block wil performe with bupivacaine 2 mg/kg as 0.2%. Supplemental analgesia will consist of as requred intraoperative remifentanyl, for recovery unit rescue tramadol, as requred at home ibuprofen. Patients wil be evaluated in the recovery unit for analgesia with FLACC pain scale, analgesic requirement, complications and parental satisfaction. Parents will be also called for analgesia and satisfaction after discharge of the patients in first 24 hours. The evaluation will be performed by a researcher whom does not know which participants belong to the caudal or ilioinguinal/iliohypogastric nerve block group

Eligibility Criteria:
Inclusion Criteria:1- 10 year- old who were scheduled to bilateral inguinal hernia surgery -

Exclusion Criteria: Patients with neurological disoder, reoperation for inguinal hernia surgery, coagulation disorder

-
Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir

This is a drug-drug interaction study to assess the effects of a single dose of PF-07321332/ritonavir after multiple dose administrations of carbamazepine. Pharmacokinetic (PK) will be evaluated for PF-07321332 and ritonavir. Carbamazepine is being utilized as a cytochrome P450 3A4 (CYP3A4) inducer.


Eligibility Criteria:
Inclusion Criteria:

1. Female participants of childbearing potential must have a negative (urine or serum) pregnancy test.
2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

1. Positive test reverse-transcriptase polymerase chain reaction (RT-PCR) result for SARS-CoV-2 infection at the time of Screening or Day -1.
2. Subjects shown to carry or be positive for human leukocyte antigen (HLA)-B\*1502 and HLA-A\*3101
3. Participants taking monoamine oxidase inhibitors (MAOIs) should discontinue MAOI for a minimum of 14 days prior to dosing in the current study.
4. Hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, vaginal ring, and postcoital contraceptive methods) and hormone replacement therapy must have been discontinued at least 28 days prior to the first dose of investigational product. Depo Provera must be discontinued at least 6 months prior to the first dose of study treatment.
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients

This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. The first dose will be self-administered at the trial site under the supervision of the investigator and the second dose will be self-administered at home.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a history of migraine (according to the ICHD-3 criteria) diagnosis for ≥12 months prior to giving informed consent.
* Patient fulfills any of the migraine criteria(according to the ICHD-3 criteria) on ≥4 days in baseline information collected during the 28-day screening period

Exclusion Criteria:

* History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
* Prior exposure to a monoclonal antibody targeting (CGRP) pathway meeting the following conditions:

  * Less than 5 months has passed since the final administration of AMG334, ALD304, or LY2951742.
  * Less than 1 year has passed since the final administration of TEV-48125
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia

Objective - Type 2 uncontrolled diabetic patients often have low endogenous melatonin and suffer from sleep disorders. The effect of a prolonged-release melatonin (PRM) formulation on glucose lipid metabolism and sleep is studied in type 2 diabetes patients with insomnia.

Methods: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks with 1 tablet per night of 2 mg prolonged-release melatonin or placebo, with one week washout period in between. Sleep was objectively monitored by wrist actigraphy. Fasting glucose, fructosamine, insulin, C-peptide, triglycerides, cholesterol (total, HDL and LDL) and some antioxidants were assessed at baseline and end of each period.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with proven presence of the disease who complained of insomnia.

Exclusion Criteria:

* Patients with liver or renal problems (serum creatinine above 1.5 mg/dL).
Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache

The study titled \&#34;Transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache\&#34; is a randomized controlled pilot study aimed at evaluating the efficacy of a transnasal sphenopalatine ganglion (SPG) block in addition to standard pain medication for reducing headache severity in patients with acute subarachnoid hemorrhage (aSAH). The study also examines whether this intervention can reduce opioid requirements during hospitalization and upon discharge.

The study is designed to test the hypothesis that the addition of a transnasal SPG block to standard pain medication is more effective than medication alone in reducing headache associated with acute subarachnoid hemorrhage. It involves 40 participants who meet specific inclusion criteria, such as being over 18 years old, having a secured aneurysm, and the ability to verbalize pain scores. Those with conditions like recent nasal or facial trauma, allergies to specific anesthetics, or pregnancy are excluded.

Participants are randomized into two groups: one receiving the standard care medication for headache and the other receiving both the standard care and a transnasal SPG block. The SPG block is administered using a needleless device called the Tx360, which allows for the medication to be instilled directly to the the sphenopalatine ganglion via the nasal passageways.

Data on pain scores and opioid usage are collected and analyzed using statistical methods to assess the effectiveness of the SPG block. The study also includes safety monitoring to track any adverse effects from the intervention. The entire study spans approximately 24 months, with individual participation lasting up to four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Acute subarachnoid hemorrhage
* Age greater than 18 years
* Secured aneurysm
* Patient can verbalize pain score to clinician, nurse, medical translator, or surrogate decision
* maker
* Patient or surrogate decision maker is available to consent

Exclusion Criteria:

* Less than 18 years old
* Unsecured aneurysm
* Pregnant or lactating
* Prisoner
* Unable to verbalize pain score to clinician, nurse, medical translator, or surrogate decision maker
* Nasal or facial trauma or surgery within the last three months
* Allergy to lidocaine, bupivacaine, or dexamethasone
* Patient is unable to consent and no available surrogate decision maker
Clinical Evaluation of a Novel Incisional NPWT System

A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the suitability, safety and efficacy of the system for the management of closed surgical wounds

The purpose of this investigation is to test the functionality of a novel, non-electric NPWT device: npSIMS (negative pressure Surgical Incision Management System) from Aatru Medical LLC (Ohio, USA) which uses an exothermic chemical process to extract the oxygen from the air contained within the dressing (air contains 21% O2) and hence bring and maintain the system to between -160 and -80 mmHg below atmospheric pressure (760 mmHg). The dressing and the chemical reaction pump module can be manufactured for significantly less than the cost of electromechanical NPWT systems and can be profitably marketed at a discount to the cost of existing commercial devices. The Aatru Medical NPWT system could transform the economics and increase the availability of this therapy across the world.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is male or female ≥ 18 years of age 2. Participant will undergo an elective sternotomy, thoracotomy, caesarean section (C-section) or skin surgery incision with closure by sutures or staples 3. Participant will undergo a surgical procedure resulting in a closed approximately linear incision between 5 cm and 13 cm in length inclusive so that the npSIMS dressing covers the wound with a minimum of 1 cm overlap at each end 4. Participant is willing and able to take part in the study and provide written informed consent.

-

Exclusion Criteria:

1. Participants will undergo post-surgical radiotherapy or chemotherapy
2. Participants who, in the opinion of the Investigator, have an existing health condition that would compromise their participation and follow-up in this study
3. Participant will undergo emergency surgery
4. Participant is sensitive to or known to have allergies to silicone/acrylic adhesives
5. Participant has malignancy in the wound bed or margins of the wound
6. Participant has wound with confirmed and untreated osteomyelitis
7. Participant has wound with non-enteric and unexplored fistulas
8. Participant has wound with necrotic tissue with eschar present
9. Participant has exposed arteries, veins, nerves or organs
10. Participant has exposed anastomotic sites
RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation

This Phase II open label study will evaluate the safety and efficacy of repeat doses of RGI-2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). These subjects will be compared to contemporary controls.

This is an open-label, multi-center, single-arm study to evaluate six weekly doses of RGI-2001 in combination with standard of care treatment for the prevention of aGvHD in subjects following alloHSCT. The study will include a Safety Run-in Phase to assess the safety and tolerability of 6 weekly doses of RGI-2001 followed by an Expansion Phase in which the potential efficacy of 6 weekly doses of RGI-2001 in addition to standard of care for GvHD prophylaxis will be assessed. Comparison will be made to a contemporaneous control group.

Eligibility Criteria:
Inclusion Criteria:

1. Ages ≥ 18 and ≤ 65 years of age
2. Has a hematologic malignancy which includes Acute myelogenous leukemia (AML), T or B cell acute lymphoblastic leukemia (ALL) Myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), myeloproliferative disorder (MPD) including myeloid metaplasia and CML
3. Must have adequate organ function
4. Transplant Donor: Matched related donor or Unrelated donor
5. Is a candidate for anti-graft-vs-host-disease (GvHD) prophylaxis that includes a calcineurin inhibitor
6. Ability to understand and willingness to sign a written informed consent form
7. If female of childbearing potential, must have had a negative serum pregnancy test prior to enrollment and must have agreed to use a double barrier method of contraception for 30 days after RGI-2001 administration
8. If male, must be sterile or willing to use an approved method of contraception from the time of informed consent to 90 days after last dose of RGI-2001 administration

Exclusion Criteria:

1. Has had any other prior organ transplantation
2. Planned procedure to deplete regulatory T cells from donor transplant materials
3. Planned reduced intensity conditioning
4. Has had prior treatment with anti-CD3, other T cell depleting antibodies, or anti-thymocyte globulin within 12 months prior to alloHSCT procedure
5. Has progressive underlying malignant disease including post-transplant lymphoproliferative disease
6. Has evidence of active central nervous system (CNS) disease including known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of CNS involvement)
7. Is female and pregnant or lactating
8. Has a documented history of uncontrolled autoimmune disease or on active treatment
9. History of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to receiving study drug
Hypertonic Saline-hetastarch in Cardiac Surgery

Cardiopulmonary bypass(CPB) is associated with increased fluid extravasation and edema formation. A continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch (HSH)during CPB reduced fluid extravasation and total fluid gain during bypass in an animal model. We hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions in patients undergoing coronary artery bypass with CPB.

Cardiopulmonary bypass (CPB) is associated with fluid overload and edema formation occasionally resulting in vital organ dysfunction affecting heart, respiratory system , gastrointestinal tract and brain. Hyperosmolar/hyperoncotic preparations (HSH/HSD) have been used in cardiac surgery essentially with the aim to mobilize fluid excess and improve postoperative cardiorespiratory function.Most studies dealing with the administration of HSD or HSH during and after CPB, have used protocols recommended for treatment of severe hypovolemia and shock, that is 4 mL/kg as a bolus, given within minutes.In animal experiments we have used HSD or HSH, 1 mL/kg/h to a total dose of 4 mL/kg during CPB. The use of HSH/HSD reduced the total fluid gain about 50 % and resulted in significantly lower content of tissue water in vital organs as heart and lungs. In the actual clinical trial we hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions monitored with the PiCCO system in patients undergoing coronary artery bypass with CPB.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective coronary artery bypass graft surgery

Exclusion Criteria:

* Age \<18 years or \> 75 years
* BMI\< 18 or \> 30
* Left ventricular ejection fraction \< 40%
* Emergency operations
* Additional valvular diseases
* Impaired renal function
* Serum sodium\> 145 mmol/l
* Hematocrit\< 30%
* Use of clopidogrel the last 5 days
A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects aged from 18 to 45 years;
2. Subject has a Body Mass Index (BMI) between 18.5 and 28.0 kg/m2 at screening and the weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg;;
3. Subjects who voluntarily participate and sign informed consent form;
4. Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure;
5. Subjects willing to use reliable contraceptive methods throughout the trial and for 6 months after trial completion.

Exclusion Criteria:

1. Medical history (current or past) that in the investigator's judgment may interfere with trial participation;
2. Surgical/medical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks;
3. Occurrence of protocol-defined exclusionary events within 3 months prior to investigational product administration;
4. Use of any prescription/non-prescription medications (including herbal products) within 2 weeks prior to dosing;
5. Known hypersensitivity to any component of the investigational product or history of severe allergic reactions;
6. Positive serology for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis serum reaction;
7. Substance abuse history within 1 year prior to screening or positive urine drug screen;
8. Alcohol abuse history within 1 year or positive alcohol breath test;
9. Smoking ≥5 cigarettes/day on average during 3 months prior to screening;
10. Pregnant or lactating women;
11. Positive pregnancy test before study drug administration, or male and female subjects who refuse to use effective contraceptive methods during and for 6 months post-trial, or who have plans to donate sperm or eggs;
12. Poor compliance or any other condition that in the investigator's opinion renders the subject unsuitable for trial participation.