cyrilzakka/clinical-trials huggingface dataset:
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.

Specifically, the objectives of this study are to:

1. Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age and previously vaccinated to smallpox. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.
2. Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age by comparing:

   1. the proportion of subjects at each dose level who develop a major cutaneous reaction
   2. the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30.
3. Determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age, with a history of smallpox vaccination.

Eligibility Criteria:
Inclusion criteria:

* have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar.
* females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children.
* agree to be available for the entire study and agree to comply with all requirements.

exclusion criteria:

* children 1 year of age or younger in the household or be in close contact
* smallpox vaccination within ten years
* known or suspected Human immunodeficient virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above.
* renal disease
* current or past history of eczema or a household member or direct contact who has eczema.
* known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B
* known allergy or past allergic reaction to blood products.
* known allergy to cidofovir or sulfa-containing drugs.
* history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome.
* transfusion of blood or treatment with any blood product.
* current or history of drug or alcohol abuse
* innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
Evaluation of AN777 in Elderly Subjects

To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subject (male or female) is at least 65 years of age
2. Subject has a Geriatric Nutritional Risk Index (GNRI)of 92 or over
3. Subject has Body Mass Index (BMI) \> 20.0 but \<30.0
4. Subject is ambulatory
5. Subject agrees to maintain current activity level

Exclusion Criteria:

1. Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study
2. Subject has current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix
3. Subject has stated immunodeficiency disorder
4. Subject has stated history of diabetes
5. Subject has stated presence of partial or full artificial limb
6. Subject has stated kidney disease
7. Subject has stated history of uncontrollable hypertension
8. Subject had myocardial infarction within the last 3 months
9. Subject had recent antibiotic use (within 1 week prior to screening).
10. Subject has a history of allergy to any of the ingredients in the study products
11. Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other major gastrointestinal disease
12. Subject has stated uncontrolled severe diarrhea, nausea or vomiting
13. Subject has untreated clinically significant ascites, pleural effusion or edema
14. Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition that may interfere with study product consumption
15. Subject is actively pursuing weight loss
16. Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma or chronic obstructive pulmonary disease, topical or optical steroids and short-term use (less than two weeks) of dexamethasone
Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

The purpose of this study is to evaluate if the use of Neuromuscular Electrical Stimulation (NMES) will provide a more efficient method of treating neonates with dysfunctional oral feeding such as dysphagia. This study will attempt to determine if NMES applied to neonates at 36-42 weeks post-conception age (PCA) will decrease the need for nasogastric tubes (NG) and gastrostomy tubes (G-TUBE). Increase the rate at which these neonates complete full oral feeds, improve their swallowing skills, increase oral intake of calories, and gain weight.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Meet diagnostic criteria for dysphagia symptoms using the NOMAS and a VFSS.
* Infants with intraventricular hemorrhage (IVH) and hypoxic events can be included.
* Infants taking less than 5-10% of target volume by mouth between the ages of 36-42 weeks PCA.
* Multiple swallows to clear bolus following suck that includes a desaturation \<80% and bradycardia \<80 bpm.
* Apnea spells during feeds.
* Aspiration or penetration by VFSS

Exclusion Criteria:

* Known neurologic or neurodegenerative disorders.
* Chromosomal anomalies and syndromes.
* Cleft lip or palate.
* Birth defects.
* Unresolved cutaneous rash at the area of electrode placement.
* Medical condition that is a contraindication to NMES.
Recovery Learning for Adolescents After Traumatic Experiences

Most children who have been removed from their family home and placed under the care of a Local Authority have been exposed to many frightening experiences, including witnessing violence, not being fed or cared for, or being abused. These experiences can lead to significant emotional difficulties. One such difficulty is posttraumatic stress disorder (PTSD), which can involve symptoms like having constant "flashbacks" of scary experiences, and a constant feeling of being in danger. This can have a big effect on children's lives. Yet, it is still not clear how to help young people in care who are experiencing high PTSD symptoms.

One idea the researchers have is to use a group-based online programme which has successfully helped other young people who have been exposed to different kinds of stressful experiences (for example, war). To test whether this programme could help children in care too, the researchers first need to see whether social workers have the time to check in with a child about PTSD symptoms; whether young people and their carers are willing to be involved in a research project which will test out the treatment programme; and whether mental health workers might face any problems when delivering the programme. This project aims to answer these questions.

The researchers will train social workers to complete an 8-question interview with 10-17 year olds in care, which will measure symptoms of PTSD. If the young person is experiencing high symptoms, they will be invited to take part in a research project. If they would like to join the project, children will be randomly selected to take part in the online group programme, or be given care-as-usual. The group programme involves the young person taking part in five weekly meetings held online, where they will learn skills to reduce their distress, and be supported to work through their difficult memories. Their carers will also take part in two online meetings which will teach them how to support their young person.


Eligibility Criteria:
Inclusion Criteria:

* Experiencing elevated PTSS (using a standard cut-off score of =/\> 17 on the 8-item Child Revised Impact of Events Scale; CRIES-8).
* Living in any care residence (with the exception of those living with a biological parent).
* Access to appropriate technology to engage in the online sessions and can do so in a quiet and private space.

Exclusion Criteria:

* A diagnosis of psychosis.
* Current and active serious suicidal ideations.
* A moderate to severe learning disability.
* Currently receiving direct therapeutic mental health support.
Postoperative Analgesia of Magnesium Sulfate in Suprascapular Nerve Block Following Shoulder Arthroscopy

* Arthroscopic shoulder surgeries in adults are accompanied with severe immediate postoperative pain reported in approximately 45% of patients. For quicker recovery and rehabilitation of these patients, postoperative analgesia is mandatory.
* Different analgesic modalities have been proposed including parenteral opioids, intra-articular injection of local anesthetics, interscalene brachial plexus block (ISB), and a suprascapular nerve block (SSNB), with varying degrees of effectiveness and multiple reported side effects.
* A recent meta-analysis demonstrates that suprascapular block results in 24-h morphine consumption and pain scores similar to ISB, so, it may be considered an effective and safe alternative for interscalene block in shoulder surgery, with less motor restriction, and fewer complications.
* Different agents are used as adjuvants to local anesthetics during peripheral nerve block to prolong its analgesic action including magnesium sulfate.
* A meta-analysis by Mengzhu et al., concluded that magnesium sulfate combined with local anesthetics in perineural nerve blocks provided better analgesic efficacy and may be a promising analgesic for perineural nerve blocks.
* Antinociceptive effects of magnesium are due to the regulation of calcium influx into the cell and a non-competitive antagonism of the NMDA receptors

The aim of this study is to evaluate the effects of magnesium sulfate as an adjuvant to bupivacaine in suprascapular nerve block on the duration and quality of postoperative analgesia following shoulder arthroscopy, postoperative pain VAS scores, intraoperative fentanyl requirements, sedation scores, respiratory depression, postoperative 24 hours cumulative morphine consumption.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III

Exclusion Criteria:

* Patient's refusal
* Significant cardiac diseases
* Significant hepatic diseases
* Significant renal diseases (serum creatinine ˃ 1.5 mg/dl)
* Cardiac conduction abnormalities
* Drug abuse
* Pregnancy
* Allergy to study medications
* Mental disease
* Communication barrier
* Coagulopathy
* Local skin infection
* Traumatic nerve injury of upper limb
* Patients receiving opioid analgesics
* Patients receiving magnesium sulfate
* Patients receiving beta blockers
* Patients receiving calcium channel blockers
* Previous shoulder surgery
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis

The purpose of this study is to confirm the clinical efficacy and the safety of P-3073 in patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and concomitant mild to moderate plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent before starting any study related procedures
* Patients aged 18 to 80 years old of any race.
* Males or females.
* Patients with mild to moderate psoriastic fingernail(s) defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline.
* In case of skin involvement, patients with established clinical diagnosis of mild-to-moderate psoriasis (BSA involvement ≤ 8% or PASI ≤ 10)

Exclusion Criteria:

* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Use of any systemic treatment for psoriasis during the last six months before the screening visit.
* Use of photochemotherapy or other forms of radiotherapy during the last four weeks before the screening visit.
* Positive mycology findings
* Systemic use of immunosuppressives, chemotherapy and corticosteroids during last three months before the screening visit.
* Consumption of Vitamin D or its analogues during the last three months.
* History of hypercalcaemia or hypercalciuria.
* HIV infection or any other immunodeficiency.
* Alcohol or substance abuse.
* Patients with history of allergic reactions to calcipotriol or its excipients.
Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the dose of remifentanil.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Rapid sequence induction
* Recent sore throat
* Recent upper respiratory infection
* Asthma
* Chronic obstructive pulmonary disease
* Chronic cough
* Pregnancy
* Allergy to remifentanil
* Friable teeth
* History of head and neck surgery
* Multiple intubation attempts
* Regional anesthetic agents
* Gastric tube
* Dexamethasone
Postoperative Analgesia of TAP Block for Laparoscopic Sleeve Gastrectomy

many methods were considered to control postoperative pain in laparoscopic bariatic surgery including non steroidal anti-inflammatory drugs, opioids and neuraxial block

but subcostal (TAP) block has provided good analgesic effect when used as a part of multimodal analgesia in bariatric surgery due to lack of visceral block

Since long time opioid have been used to control postoperative pain in bariatric surgery However, an increasing awareness of opioid-related adverse events, including respiratory depression, paralytic ileums, and sedation, constipation has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia As neuroaxial block and ultrasound guided nerve blocks

As the transverse abdominis plane (TAP) block which is of increasing interest nowadays (Basaran B, et al 2015)

The ultrasound-guided oblique SCTAP block, first described by Hebbard et al., has the potential to provide analgesia for both upper and lower abdominal surgery. There is a growing consensus that the SCTAP block provides better analgesia for upper abdominal incisions

The TAP block via various approaches provides some advantages over neuraxial anesthesia (Ganapathy Set al 2015). For example, TAP blocks are associated with a lower use of intraoperative phenylephrine and a lesser degree of intraoperative blood pressure changes. The SCTAP block may be utilized in cases in which neuraxial anesthesia is contraindicated, such as patients with coagulation issues or infection at the epidural puncture site. Although the SCTAP block provides sensory blockade of the abdominal wall, it is lacking in coverage of visceral pain (Lissauer J,et al 2014).

The lack of visceral pain analgesia may require the use of additional methods of postoperative pain control such as intravenous opioids or non-narcotic analgesics.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-60 years
* ASA Ι-ΙΙ
* BMI \>35

Exclusion Criteria:

* Patient refusal.
* Allergy to study drugs.
* Infection at site of injection.
Exploratory Study of the Digital Therapeutics CT-155 in the Treatment of People With Schizophrenia

CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based intervention to treat schizophrenia

CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI). CT-155 delivers an interactive, software-based intervention for schizophrenia. During a PDT development lifecycle, iterations of the PDT may be scientifically evaluated in a user population that is clinically representative of the intended patient population. Data generated via this evaluation can be used to drive the modification and optimization of specific therapeutic components contained within a given PDT.

Eligibility Criteria:
Inclusion Criteria:

* 1. Has outpatient treatment status of schizophrenia.
* 2. Is on a stable dose of antipsychotic medication(s)
* 3. Is the sole user of an iPhone with iPhone operating system (iOS)13 or greater capabilities or a smart phone with an Android operating system (OS) 9 or greater capabilities.
* 4. Is the owner of, and has regular access to, an email address.
* 5. Has regular access to the internet via cellular data plan and/or wifi.
* 6. Willing and able to receive SMS text messages on their smartphone and email messages, and understand how to use the downloaded Study App.
* 7. Has stable housing and has remained at the same residence for at least 12 weeks prior to screening, with no anticipated housing changes during the duration of the study

Exclusion Criteria:

* 1. Is currently treated with more than two antipsychotic medications.
* 2. Is currently treated with clozapine or haloperidol.
* 3. Has active prominent positive symptoms to preclude effective engagement in treatment for negative symptoms.
* 4. Is currently receiving or has received psychotherapy within 12 weeks prior to screening.
* 5. Meets either the International Classification of Diseases (ICD-10) or DSM-5 criteria for diagnoses not under investigation.
* 6. Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder.
* 7. Has substance or alcohol use disorder.
* 8. Currently needs or will likely require prohibited concomitant medications.
* 9. Is currently participating in another clinical study.
* 10. Prior participation in the CT-155-C-001 clinical study.
* 11. Has suicidal ideation or behavior.
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults with Active Idiopathic Inflammatory Myopathy

The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.


Eligibility Criteria:
Inclusion Criteria:

* Has completed trial ARGX-113-2007
* Being capable of providing signed informed consent and complying with protocol requirements
* Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the investigational medicinal product

Exclusion Criteria:

* Intention to have major surgery during the study period; or any other medical condition that has arisen since enrollment in study ARGX-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk
* Known hypersensitivity reaction to investigational medicinal product or 1 of its excipients Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness
* Permanent discontinuation of IMP in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit
* Diagnosis with a deselected subtype of myositis based on the analysis of the phase 2 stage data in ARGX-113-2007, unless the investigator determines that the participant is benefiting from IMP as defined by a score of "much better" or "moderately better" on the 'Clinical Global Impression of Change' and 'Patient Global
* Impression of Change' assessments for at least 12 weeks, and that enrolling in the study is in the participant's best interest
Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery

This study aims to assess the safety of using continuous regional anesthesia for post-operative analgesia during septic limb orthopedic surgery.

The study hypothesis is that continuous regional anesthesia would not induce septic complication in the operated limb and could improve post-operative recovery.


Eligibility Criteria:
Inclusion Criteria:

* Osteo arthritis or cellulitis requiring surgical intervention
* anatomical possibility of regional anesthesia
* age \>18 ans
* written informed consent

Exclusion Criteria:

* loco-regional anesthesia impossibility (puncture zone infection, local anesthesics allergie, amiodarone or mexilétine treatment, neurologic deficit for exemple)
* patient under tutelle or curatelle
* pregnant or beast feeding woman
A Study of Chlorhexidine in the Prevention of HIV-1 Transmission From Mothers to Their Babies

The purpose of this study is to find the best strength of chlorhexidine (a solution that kills germs), for washing the mother's vagina during labor and the newborn baby, that may reduce the chance of HIV being passed from an HIV-positive mother to the baby.

When used as a wash on the vagina during labor, and on a newborn shortly after birth, a higher dose of chlorhexidine is more likely to reduce the rate of HIV-1 transmission from mother to baby. Laboratory tests suggest that a higher dose of chlorhexidine will be more effective in killing HIV.

The principal hypothesis of this protocol is that, in the context of routine oral/nasal suctioning of infants, a higher concentration of chlorhexidine for peripartum vaginal and postpartum newborn cleansing results in reduction in maternal child transmission (MCT) of HIV. The in vitro data suggest that a higher concentration of chlorhexidine in the primary wash solution is much more likely to have a virucidal effect perinatally and thus reduce MCT.

Perinatal intervention consists of the following: 1) cervicovaginal wash of the entire birth canal with a chlorhexidine solution at the time of each vaginal examination of a mother in labor; 2) immediate suctioning of the nasal and oral passages of the infant at the time the head emerges (fluids to be tested for viral load at future date); and 3) thorough washing of the baby with a chlorhexidine solution immediately after delivery. Blood samples are collected from some infants for measurement of chlorhexidine levels approximately 2 hours post-washing. During the 24 to 48 hours following delivery, infants are examined and mothers are queried using standardized questionnaires for subjective complaints related to the chlorhexidine washes. Speculum-aided vaginal exams are done for any persistent (greater than 24 hours) or severe complaints.

Eligibility Criteria:
Inclusion Criteria

Mothers may be eligible for this study if they:

* Receive HIV testing and counseling (both HIV-positive and HIV-negative women will be enrolled).
* Are at least 36 weeks pregnant.
* Are receiving routine prenatal care at the Chris Hani Baragwanath Hospital maternity unit in Soweto, South Africa.

Exclusion Criteria

Mothers will not be eligible if they:

* Have severe complications during the pregnancy, such as bleeding before birth.
* Have a C-section by choice.
* Have obvious genital sores at the time of labor.
* Have a baby that is positioned a certain way during delivery.
* Receive prostaglandin tablets, in the vagina, during labor.
* Have major medical conditions, such as TB or diabetes (except HIV, in HIV-positive women).