cyrilzakka/clinical-trials huggingface dataset:
Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

The purpose of this research is to study the effects of nasal oxytocin administration on maternal behaviors that may be influenced by cocaine use during pregnancy. 32 mothers with prenatal use of cocaine during the current pregnancy will be studied at 3-6 months postpartum, when they will complete 3 study visits, a 2-week double-blind trial of twice daily nasal spray (oxytocin or placebo) and 4 telephone interviews. All information collected is confidential.

Participation for mothers when they are 3-6 months postpartum includes:

* Visit 1: Questionnaires and interviews about participants' health, pregnancy, moods, psychological history and drug use during pregnancy and postpartum.
* Visit 2: Pregnancy \& drug tests (results are confidential), blood samples and vital signs, video-taped mother-infant interaction, speech task, instruction re: using nasal spray (oxytocin or placebo) \& self-administration of first nasal spray dose, followed by 90 minutes of monitoring.
* At-home nasal spray: Twice daily (before breakfast and supper) nasal spray self-administration for 14 days.
* Visit 3: Pregnancy \& drug tests (results are confidential), blood samples and vital signs, video-taped mother-infant interaction, speech task, interviews and questionnaires about mothers' experience with the nasal spray, and changes in mood or physical discomfort during the 2-weeks when taking the nasal spray.
* 3 telephone interviews while subjects are taking nasal spray, and 1 post-trail telephone follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 3-6 months postpartum at start of testing
* Cocaine use during current pregnancy (by self-report or medical record of prenatal urine toxicology)
* Exclusive Formula-feeding for all infant milk feedings (no infant feeds will be breast milk)
* Healthy singleton pregnancy
* English fluency that will allow informed consent

Exclusion Criteria:

* Pregnancy or plans to become pregnant during participation in the study
* Not using effective birth control methods to prevent pregnancy
* Breastfeeding for any infant milk feedings
* Mother is not currently living with the infant during the trial period
* Multiple birth (twin, triplet or greater)
Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration

The purpose of this study is to evaluate anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.

Subjects with age-related macular degeneration who meet inclusion and exclusion criteria will be randomized to receive monthly intravitreal injections of ranibizumab (Lucentis®) with either Squalamine Lactate Ophthalmic solution 0.2% or placebo eye drops twice a day for 6 months. Subjects will be evaluated with clinical and imaging techniques.

Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older
* A diagnosis of choroidal neovascularization secondary to age-related macular degeneration (AMD) with choroidal neovascularization (CNV) comprising at least 50% of the total lesion area in the study eye
* Central retinal thickness ≥ 300 μm and presence of subretinal fluid or cystoid edema by Optical Coherence Tomography (OCT)
* Best Corrected Visual Acuity (BCVA) of 20/40 to 20/320 by Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol

Exclusion Criteria:

* Neovascularization secondary to any other condition than AMD in the study eye
* Blood occupying greater than 50% of the AMD lesion, or blood \> 1.0 sq. mm underlying the fovea
* PED without associated subretinal fluid and/or cystic retinal changes
* Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
* Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease)
* Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement
* Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye
Observational Study of Blood Treated With Cytolin

Primary Objective: To determine the mechanism of Cytolin's effect on HIV replication from blood drawn from HIV-positive and HIV-negative individuals after exposure to Cytolin.

The initial phase of this in vitro study regarding the potential mechanisms of action of Cytolin was completed in January 2011. Given the data set to date, a decision has been made to extend the study. The extension will allow the Company to further confirm and extend the initial findings regarding the potential mechanism of action of Cytolin.

Eligibility Criteria:
Early HIV Infection

Inclusion Criteria:

* HIV seropositive
* viral load \< 100,000 copies/ml
* CD4+ \> 350 cells/ul
* Ability and willingness to give written informed consent.

Control Group

Inclusion Criteria:

* HIV seronegative subjects identified as HIV uninfected by a nonreactive HIV 1/2 ELISA.
* Ability and willingness to give written informed consent.

Exclusion Criteria:

* Presentation with an opportunistic infection or AIDS-defining illness.
* Receipt of investigational research agent within 30 days prior to study entry.
* Prior receipt of experimental HIV vaccine, sham vector or adjuvant.
* Receipt of immunosuppressive medications or immune modulators within the past six months. Individuals taking corticosteroid nasal spray for allergic rhinitis, topical steroid or over the counter medications for acute, uncomplicated dermatitis for a period no longer than 14 days will not be excluded.
* Active drug or alcohol use, dependence or psychiatric illness that in the opinion of the study investigator would interfere with adherence to study protocol.
* Serious illness requiring hospitalization.
Evaluation of Multifocal ERG and Visual Field Changes After Vitrectomy and ILM Peeling

To evulate changes in MfERG, VF and OCT after viterctomy associated with ILM peeling.

Macular epiretinal membrane (ERM) is a disorder of the vitreomacular interface characterized by ﬁbrocellular proliferation on the anterior surface of the internal limiting membrane (ILM) of the macula. Pars plana vitrectomy with ERM removal and inner limiting membrane peeling is the standard surgical treatment for an ERM. ILM peeling is performed to eliminate the scaffold for myoﬁbroblast proliferation and any microscopic ERM in order to prevent ERM recurrence. ILM peeling is indicated for other pathologies other than ERM such as, diabetic macular edema, and macular hole. ILM peeling is a traumatic procedure that may have many effects on the underlying inner retinal layers that may lead to changes in retinal function.

Retinal edema, eccentric scotoma, dissociation of the nerve fiber layer, iatrogenic punctuate chorioretinopathy, and subretinal, retinal, and vitreous hemorrhage are well described secondary to the surgical trauma of peeling in addition to stain toxicity. Investigation of these changes may assist in aiding the development of minimally traumatic techniques for ILM removal .

Evaluation of functional changes may include visual field and Multifocal electroretinography assessment. Visual field defect after vitrectomy a well known post operative complication usually in eyes that underwent fluid air exchange, the cause of visual field defect remain unclear.

Optical Coherence Tomography (OCT), imaging is done to evaluate inner retinal layers after ILM peeling,High myopic eyes might develop more severe, "scattered" inner retinal defects after ILM peeling.

Multifocal electroretinography (mfERG), has been used to assess visual function and the electrophysiologic responses of multiple retinal locations of the macular area

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic ERM,
2. Primary full thickness macular hole,
3. Lamellar macular hole, and
4. Vitromacular traction

Exclusion Criteria:

* 1-Patients with a secondary ERM,

  1. diabetic retinopathy,
  2. venous occlusion,
  3. retinal detachment,
  4. uveitis, and
  5. trauma. 2-Other ocular pathologies that could interfere with the functional results

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  1. dense cataract ,
  2. glaucoma, and
  3. previous retinal surgery
AK104 in Neoadjuvant Treatment of Cervical Cancer

Phase II open label study to evaluate the safety and efficacy of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) in neoadjuvant treatment of cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 \& ≤75.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Histologically or cytologically confirmed diagnosis of primary cervical squamous cell carcinoma.
4. According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed in stage IB2-IIA2.
5. Has not received any treatment before.
6. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
7. Has adequate organ function.

Exclusion Criteria:

1. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
2. Active Hepatitis B or Hepatitis C.
3. History of severe bleeding tendency or coagulation disorder.
4. Undergone major surgery within 30 days prior to the first dose of study treatment.
5. Pregnant or lactating female patients.
6. Drug or alcohol abuse.
7. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
Effectiveness of Hypnosis Via Virtual Reality During Oocyte Retrieval

This study compares hypnosis via virtual reality to sedation with commonly used intravenous anesthetic agents (propofol and remifentanil) during oocyte retrieval.

The main objective of this prospective randomized controlled study will be a reduction of 50 percent of the doses of remifentanil and propofol administered during oocyte retrieval while maintaining satisfaction with the quality of care.

Transvaginal ultrasound-guided oocyte retrieval is a fundamental step in the treatment of in vitro fertilization (IVF).

To date, no anesthetic technique has demonstrated superiority in terms of efficacy, tolerance or analgesia.

Virtual Reality Distraction has been studied for its clinical applications.

Patients will be included during the consultation with either the gynecologist or the anesthetist who will explain the protocol to the patient and give her consent to sign.

After obtaining their informed consent, the patient will be randomized into two groups based on a computer-generated randomization list (QuickCalcs program; GraphPad Software Inc) either into the experimental or in the control group.

In the experimental group, patients will benefit from a 20-minute virtual reality. Patients will watch a forest walk in virtual reality while listening to narrations designed to induce relaxation and meditation. If the oocyte retrieval was not completed within 20 minutes, the patient will watch the virtual reality program again. The target-controlled infusion of remifentanil and propofol will be connected to the patient, and only titrated to patient's comfort.

In the control group, patients will immediately benefit from an infusion of remifentanil and propofol titrated in a well-protocolized manner according to the patient's comfort.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients undergoing oocytes retrieval for in vitro fertilization

Exclusion Criteria:

* Presence of any psychiatric disorders
* Presence of a visual acuity disorder or hearing abnormality.
* Dementia
* Limited knowledge of French
* Diagnosis of balance disorders or epilepsy
* Claustrophobia
* Stage 4 endometriosis.
Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes

Cardiovascular disease (CVD) is an important public health problem that affects millions of people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or hypertension, and prevalent CVD are well documented. However, few studies have investigated associations with onset of disease. The initial manifestation of CVD, for example an episode of unstable angina, is important because it influences the prognosis, the quality of life and the management of disease. Furthermore, the extent to which social deprivation, alcohol consumption or atrial fibrillation affects presentation of CVD is poorly understood and deserves further consideration.

Most previous studies have considered CVD as a single entity. However, differences in aetiology between coronary phenotypes suggest that risk factors may not be shared across specific coronary phenotypes and their relative importance is likely to differ for each phenotype. Gaining knowledge of these differences could provide insights into the pathophysiology of specific forms of CVD and could eventually lead to modification of recommendations for patient management and disease prevention.

We propose to use the linkage of the national registry of coronary events to general practice records in the Clinical Practice Research Database (CPRD), to investigate whether demographic, behavioral, and clinico-metabolic risk factors differentially influence the onset of specific types of CVD.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥30yrs old
* Registered in CPRD practices in England consenting to data linkage
* ≥1 year of up-to-standard pre-study follow-up

Exclusion Criteria:

* History of any of the CVD endpoints considered before study follow-up initiation.
Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug approved to reduce the short and long-term occurrence of dry mouth when patients receive radiation treatment for head and neck cancer. Some studies have shown that Amifostine reduces the side effects of radiation treatment for lung cancer. The use of Amifostine is still being investigated in lung malignancies. Amifostine is found to be a protectant from radiation side effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus, kidney and testes. Patients that receive radiation treatments for lung cancer may experience side effects involving the esophagus. It is hoped that patients will benefit from the protection of their esophagus and avoid delays in radiation treatment due to side effects of the radiation.

The protective capacity of thio-containing compounds against normal tissue damage from radiation have been recognized for over 40 years..

Although intravenous administration is the approved standard route, because of practical advantages there has been increasing interest in the subcutaneous administration of Ethyol, which presents multiple advantages when used for radioprotection.

Based on the data that has been presented, as well as the personal experience of this and other physicians/centers with subcutaneous administration of amifostine, the researchers are proposing an open-label study evaluating the rate and severity of toxicities associated with this route of administration. Toxicities to be assessed include nausea/vomiting, hypotension, and skin/fever reactions.

Eligibility Criteria:
Inclusion Criteria:

* Patient is eligible to receive subcutaneous amifostine under site's current practice guidelines for radioprotection.
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2
* Age \> 18
* Patient receiving radiation therapy or combined modality therapy to treat malignancy.
* No evidence of distant metastatic disease.
* Granulocyte count (segs \& bands) \> 2000/mm3 and platelet count \> 100,000/mm3
* Serum creatinine \<2.0mg/dL
* Total bilirubin \<2.0mg%, SGOT \< times the upper limit of normal.
* Patients may not be entered on investigational therapeutic trials.
* Patients or guardians must be informed of and understand the investigational nature of this study and give written informed consent prior to any study procedures.

Exclusion Criteria:

* Life expectancy of \<6 months
* Patients receiving only chemotherapy to treat malignancy.
* Patients who have been treated with any investigational drugs \<4 weeks prior to study entry.
* General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent.
* Pregnancy; Women of childbearing potential should use an effective (for them) method of birth control throughout their participation in this study.
* Patients who are currently receiving or have received amifostine for radioprotection within the prior 6 months are excluded.
Conjugated Hyperbilirubinemia and Pulse Oximetry

The purpose of this study is to determine if higher levels of bilirubin in the blood of people with liver disease affects how accurate a pulse oximeter machine is able to measure the concentration of oxygen in the blood. Previous studies have reported conflicting results regarding the affect of high levels of bilirubin in the blood on the accuracy of the pulse oximeter reading. Initial studies showed an underestimation of the oxygen concentration in the presence of elevated bilirubin. Subsequent studies have suggested that high levels of bilirubin in the blood do not influence the accuracy of the pulse oximeter machine. However, recent reports in bone marrow transplant literature and our personal observations in patients with liver disease suggest that high bilirubin levels are associated with an overestimation of the oxygen concentration as measured by the pulse oximeter machine.


Eligibility Criteria:
Inclusion Criteria:

* Patients with established liver disease or dysfunction, as determined by abnormal liver function tests, imaging, or biopsy

Exclusion Criteria:

* Patients with unconjugated hyperbilirubinemia, which could be associated with elevations in carboxyhemoglobin
* Patients with poor peripheral perfusion that would compromise accurate pulse oximetric determination
Residual Neuromuscular Block of Rocuronium in Chemotherapy Patients Under Sevoflurane Anesthesia

Chemotherapy causes motor nerve dysfunction and degeneration that may alter the response to neuromuscular blocking drugs. To analyse the risk of residual neuromuscular block (RNMB) induced by rocuronium given in standard doses to patients who undergo chemotherapy within three months.

Rocuronium, as a non depolarizing muscle relaxant with medium time effect, takes effect rapidly. It is an ideal neuromuscular blocker to replace succinylcholine for induction of tracheal intubation and maintenance of muscle relaxant under general anesthesia. Sevoflurane is widely used in clinic because of its low blood gas partition coefficient, rapid and stable induction and recovery, easy adjustment of anesthesia depth and strong controllability. In addition, the number of patients receiving preoperative adjuvant chemotherapy for malignant tumors is increasing year by year in China. The commonly used chemotherapy drugs, such as paclitaxel, platinum, vinorelbine, etc., have dose-dependent peripheral neurotoxicity. Therefore, to explore and study the influence of pathophysiological changes of patients receiving chemotherapy on the neuromuscular relaxation effect of sevoflurane combined with non depolarizing neuromuscular blockers, It is very important for anesthesia, resuscitation and perioperative management of chemotherapy patients. The purpose of this study is to reveal the effect of sevoflurane on rocuronium neuromuscular blockade in chemotherapy patients by comparing the difference of rocuronium neuromuscular blockade effect of sevoflurane and total intravenous anesthesia in chemotherapy patients and non chemotherapy patients, and to provide information for more safe and rational application of rocuronium in clinical anesthesia of chemotherapy patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients classified as American Society of Anesthesiology physical status (ASA PS) classes I, II or III
* Aged between 18 and 70 years
* Scheduled for radiofrequency ablation of liver tumours under general anaesthesia with an expected surgery duration shorter than 60min

Exclusion Criteria:

* Allergy to rocuronium
* Myasthenia gravis
* Guillain-Barre ́ syndrome
* Duchenne muscular dystrophy or similar
* Receiving drugs that might interfere with the neuromuscular transmission or the response to neuromuscular blockers, such as some anticonvulsants and antibiotics
Vellore Typhoid Vaccine Impact Trial

This cluster randomised trial will examine the impact of introducing TyphiBEV, a typhoid conjugate vaccine licensed in India, on the incidence of typhoid fever in a high burden urban setting in South India.

TyphiBEV®, a typhoid conjugate vaccine from Biological E, has been licensed by the Central Drugs Standard Control Organaisation in India based on immunogenicity and safety data. A similar typhoid conjugate vaccine has been demonstrated in large clinical trials to provide 80% vaccine efficacy in Nepal and Bangladesh. The TyphiBEV® has not been similarly evaluated. The demonstration of the impact of a city-scale typhoid conjugate vaccine introduction on the burden of typhoid will aid policy decisions on the use of typhoid conjugate vaccines in the national immunisation program.

After written informed consent, the investigators will establish stimulated passive surveillance in 72,000 individuals between 1 and 30 years of age within the Vellore Demographic Surveillance System to determine the incidence of blood-culture confirmed typhoid fever. Thirty-six thousand surveillance participants between 1 year and 30 years residing in the 30 clusters (areas) randomised to receive the vaccine will receive the vaccine at the beginning of the trial. Those in other areas will receive the same at the end of two years. Using a stimulated passive surveillance approach, those with acute febrile illness will be encouraged to visit study surveillance hospitals. Participants will be evaluated for blood-culture confirmed typhoid fever if they are eligible. The incidence of typhoid among those living in areas assigned to vaccination compared to those whose residence is in areas not designated for vaccination will be used to calculate the impact of the vaccine on disease burden.

Eligibility Criteria:
Inclusion Criteria:

* Consent

  * For adults, 18 years and over - they must be willing and competent to provide informed consent
  * For those aged under 18 years, the parent/guardian is willing and competent to provide informed consent, and if the participant is 11 to 18 years of age, informed assent will also be sought,
* Age:

  * Between 1 and 30 years (i.e., up to 29 years 364 days) at time of recruitment into the surveillance
  * Currently living within the study catchment area with no plans to leave the study area in the next 24 months

Exclusion Criteria:

* For fever surveillance

  o Medical reasons that prevent the participant from complying with study requirements including follow up and testing during illness
* For vaccination

  * Has received a typhoid vaccine in the previous three years
  * Is known to have an allergy to any vaccine component
  * Nursing mothers, Pregnancy or planning pregnancy around vaccination
  * Receipt of any other vaccine in the past 30 days (temporary exclusion)
  * Febrile illness in the 24 hours before vaccination (temporary exclusion)