cyrilzakka/clinical-trials huggingface dataset:
Progesterone for Postpartum Cocaine Relapse

The investigators propose a placebo-controlled, randomized clinical trial that would enroll 50 postpartum women with a history of cocaine abuse or dependence to assess whether progesterone (100mgs twice daily) decreases postpartum cocaine use.

Specific Aim 1: To evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo.

Hypothesis 1: Compared to women who are randomized to placebo, those assigned to progesterone will use less cocaine as measured by urine toxicology results and self-reported days of use.

Specific aim 2: To obtain information about the safety and tolerability of progesterone treatment in the postpartum period.

Hypothesis 2: Side effects for progesterone will be similar to those of placebo.

Eligibility Criteria:
Inclusion Criteria:

* Gravidas (women who delivered a baby in the past 12 weeks) who are 18 or older are eligible to participate.
* Women must meet diagnostic criteria for abuse or dependence of cocaine in the six-months prior to conception or during pregnancy.
* Women who abuse other illicit substances or alcohol would also be eligible as long as cocaine was their primary drug of abuse. If women are also opiate dependent, they must be undergoing treatment with methadone or buprenorphine. While we propose to target cocaine we will also monitor the ability of women with polysubstance use to maintain abstinence from substances other than cocaine.

Exclusion Criteria:

Women will be ineligible for the trial if they:

1. have a history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the physician investigator deems as contraindicated for participation in the study;
2. have a known allergy to progesterone or peanuts (vehicle for micronized progesterone);
3. speak a language other than English;
4. are planning on moving out of the area in the first six months after delivery;
5. are unable to understand the study or are unable to provide informed consent;
6. are currently undergoing treatment with another pharmacological agent for substance abuse treatment (with the exception of methadone or buprenorphine as above);
7. have pending incarceration;
8. are currently incarcerated;
9. are using another progestin;
10. are unwilling to accept randomization;
11. are unwilling to use a barrier method of birth control for the duration of the study to ensure that they will not become pregnant.
The Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting

The purpose of this study is to determine if embryo culture under a single CO2 setting improves blastocyst formation rate.

Following enrollment, patients will undergo ovarian stimulation and oocyte retrieval per routine as previously consented to at the clinic. IVF stimulation protocol will be at the discretion of the patient's individual provider, per routine. Intracytoplasmic Sperm Injection (ICSI) will be performed and embryos will be cultured to the blastocyst stage per routine. There are no changes to the embryology care itself, the only difference within the study is the CO2 level within the incubator pending the patient's randomization.

Eligibility Criteria:
Major Inclusion Criteria for participants:

1. Patients undergoing IVF stimulation cycle with plan for subsequent FET

Major Exclusion Criteria for participants:

1. All patients who do not voluntarily give their written consent for participation
2. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
3. Use of surgical procedures to obtain sperm
A Study of Carbon-14-Labelled [14C] LY3871801 in Healthy Male Participants

The main purpose of this study is to evaluate how much of the study drug (LY3871801), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks including the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Male participants who are overtly healthy as determined by medical evaluation
* Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²), inclusive
* Males who agree to use highly effective or effective methods of contraception

Exclusion Criteria:

* Have known allergies to LY3871801, related compounds, or any components of the formulation, or a history of significant atopy
* Have received or intend to receive any vaccination within 30 days prior to dosing until the follow-up phone call
* Have participated in a radiolabeled drug study, where exposures are known to the investigator or designee, within 4 months prior to check-in, or participated in a radiolabeled drug study, where exposures are not known to the investigator or designee, within 6 months prior to check-in
Screening for Latent Tuberculosis in Healthcare Workers With Quantiferon-Gold Assay: A Cost-Effectiveness Analysis

The ministry of health in Israel requires all health-care workers to undergo screening for latent Tuberculosis infection (LTBI) prior to starting work. This is based on the Mantoux skin test, which is notoriously unreliable.

In recent years, more specific and sensitive tests based on interferon-gamma secretion to TB antigens have come to market, and most current evidence shows that many mantoux positive persons do not have LTBI. Quantiferon-GOLD is one of these assays.

In this prospective study, we will draw blood for the Quantiferon-GOLD assay in parallel to conventional testing, and perform a cost-effectiveness analysis of the cost of the investigation and treatment of LTBI in health-care workers.

We hypothesize that in spite of the cost of screening healthcare workers with Quantiferon-GOLD tests, the reduction in need for LTBI treatment and associated costs will render the test cost-effective.


Eligibility Criteria:
Inclusion Criteria:

* Health care worker undergoing screening for LTBI

Exclusion Criteria:

* Previous tuberculosis or treatment for LTBI
* Immunosuppressed due to drug treatment, HIV, organ transplant
* Recent TB contacts
Comparison of Transdermal Fentanyl and Morphine for Oral Mucositis Pain in Nasopharyngeal Cancer Patients

The primary purpose of this study is to explore the significance of analgesic treatment for radiation-induced oral mucositis pain in patients with nasopharyngeal carcinoma during radiotherapy, and to compare the analgesic effect of morphine controlled-release tablets with that of fentanyl transdermal patch. Half of participants will receive morphine controlled-release tablets,while the other half will receive fentanyl transdermal patch.

Morphine controlled-release tablets and fentanyl transdermal patch each relieve radiation-induced oral mucositis pain in patients with nasopharyngeal carcinoma. But they do so by different mechanisms and in different effects.

Morphine is a classic strong analgesic, which has been widely used in patients with advanced cancer pain. It has achieved satisfactory results in pain control, sleep improvement and quality of life. Oral morphine has been regarded as the standard treatment for moderate and severe cancer pain.

Fentanyl transdermal patch is a system device for transdermal delivery of drugs. It is compressed on a film containing fentanyl memory. The film can continuously release fentanyl into the blood circulation and maintain stable for more than 72 hours. It is not affected by gastrointestinal PH or food, and it has no hepatic frst-pass effect, with a bioavailability of up to 92%.

This study will test the efficacy and safety of morphine controlled-release tablets compared to fentanyl transdermal patch in the treatment of pain in patients with radiation-induced oral mucositis.

Eligibility Criteria:
Inclusion Criteria:

* Patients were pathologically newly diagnosed with nasopharyngeal carcinoma and had no previous history of other tumors
* According to the treatment strategies of doctors, patients need to receive radiotherapy with or without chemotherapy (for example, neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy) or targeted therapy
* Never use a opioid before treatment
* Hematology: WBC≥4.0×109/L, ANC≥1.5×109/L, PLT≥100×109/L,Hb≥90g/L.
* Participants with the ability to assess the pain level
* Willingness to return to enrolling institution for follow-up

Exclusion Criteria:

* Patients do not conform to the inclusion criteria
* Known allergy to fentanyl, morphine, or any known component of the drug formulation
* Refuse to use of opioid drugs
* Nasopharyngeal patients with mental illness
* Current untreated or unresolved oral candidiasis or oral HSV infection
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Pregnant or Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Other contraindications or unsuitable conditions for radiotherapy
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates

The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age with histologically confirmed solid tumor carcinomas (except lung) or multiple myeloma
* Radiographic evidence of 1 or more bone lesions or lytic lesion in myeloma
* Currently receiving IV bisphosphonates
* Urinary N-Telopeptide (uNTx) greater than 50 nM BCE/mM creatinine
* Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2

Exclusion Criteria:

* More than 2 prior skeletal related events (SRE)
* Known brain metastases
* Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
* Active dental or jaw conditions which requires oral surgery
* Non-healed dental/oral surgery
* Prior administration of AMG 162
* Evidence of impending fracture in weight bearing bones
* Pregnancy or breastfeeding. Subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the study.
Stress & Social Cognition in Borderline Personality Disorder

The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior in BPD patients.

The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior, such as empathy, in BPD patients and whether this "fight-or-flight" pattern is also seen in other relevant aspects of social behavior, such as sharing and punishment behavior. To induce social exclusion all participants will play cyberball, either the exclusion condition or the (over)inclusion condition before testing

Eligibility Criteria:
Inclusion Criteria:

female patients with BPD and healthy control women, matched for age, body mass index, and education

Exclusion Criteria:

physical illness
Comparison of Volume-controlled and Pressure-controlled Ventilation in Clasp-knife Position

Carbon dioxide (CO2) pneumoperitoneum and clasp-knife positioning are commonly used to improve surgical access during robot-assisted laparoscopic urological surgery. However, these methods are sometimes associated with several unwanted cardiopulmonary effects such as increased mean arterial pressure, decreased pulmonary compliance and functional residual capacity, increased peak inspiratory pressure, and respiratory acidosis in association with hypercarbia. Volume-controlled ventilation (VCV) is the most commonly used method of ventilation during general anesthesia. It provides fixed minute ventilation and pulmonary resistance, which affect airway pressure. In pressure-controlled ventilation (PCV), constant inspiratory airway pressure can be achieved by decelerating the flow. However, minute ventilation is not fixed . CO2 pneumoperitoneum in the clasp-knife positioning can influence hemodynamic variables, including blood pressure, heart rate, and cardiac output. This is because changes in airway pressure affect intrathoracic pressure and the function of the heart itself. In this randomized study, we investigated the effects of VCV and PCV on peak inspiratory pressure during robot-assisted laparoscopic urological surgery involving CO2 pneumoperitoneum in the clasp-knife position.

After careful screening, 60 patients were enrolled in the trial. The investigators monitored patients' breathing, circulation and carbon metabolism by measuring arterial gas, cardiac output monitoring, respiratory parameters and circulation parameters at different times in both groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing urological surgery in clasp-knife position
* between the age of 18 and 65
* America Society of Anesthesiologist Grades I-II.

Exclusion Criteria:

* Morbid obesity
* systolic blood pressure \< 90 mmHg)
* heart rate \< 60 beats per minute or \> 100 beats per minute
* peripheral blood oxygen saturation \< 90%
* Complicated with severe liver and kidney injury.
A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathology diagnosis of breast cancer,Chemotherapy naïve
* ECOG performance status 0-1
* Age 18 to 70 years
* Available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy
* White blood cell ≥ 4.0×109/L; absolute neutrophil count ≥2.0 × 109/L; platelet count ≥ 100 × 109/L
* Alanine aminotransferase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN
* No obvious cardiac dysfunction

Exclusion Criteria:

* Prior bone marrow or stem cell transplantation
* Received systemic antibiotics treatment within 72 h of chemotherapy
* Other disease might have influence on bone marrow function
* Radiation therapy within 4 weeks of randomization into this study
* Previous exposure or or allergic to Pegylated rhG-CSF
* Pregnancy, lactation
Fentanyl Background Infusion for Acute Postoperative Pain

We investigated the efficacy and the safety of the pharmacokinetic model-based patient-controlled analgesia (PCA) regimens of fentanyl for postoperative analgesia after total intravenous anesthesia (TIVA).

Infusions of fentanyl (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr, or at the decremental rates of 6.0 ml/hr or 8.0 ml/hr during 1 hr, 4.0 ml/hr during 1\~3 hr and 2.0 ml/hr during 3\~24 hr, postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patients who had undergone patient-controlled analgesia (PCA) after hysterectomy

Exclusion Criteria:

* neurologic disorders
* psychiatric disorders
* renal or hepatic disorders
Registry for Pulmonary Hypertension Due to Left Heart Disease in China

Left heart disease is the main cause of pulmonary hypertension. With the advent of the aging society, chronic heart failure has become a global public health problem. Therefore the prevalence of pulmonary hypertension due to the left heart disease is increasing. However, there is no research on the prevalence of pulmonary hypertension due to the left heart disease in China. Therefore, the aim of the present study was to describe real-world outcome of Chinese patients with pulmonary hypertension due to the left heart disease and identify factors that may predict outcome. Our study will profile the demographics, clinical course, treatments, and outcomes of pulmonary hypertension due to the left heart disease in China.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary Hypertension due to left heart disease

Exclusion Criteria:

* Other forms of Pulmonary Hypertension
* Heart failure due to valvular heart disease
* Hypertrophic obstructive cardiomyopathy
* Right ventricular outflow tract stenosis
* Pericardial disease
* Patients with chronic lung disease
Study Comparing Modified Lee White Clotting Time Against Twenty Minute Whole Blood Clotting Test in Snakebite Victims

20 minute Whole Blood Clotting Test(20'WBCT) recommended by World Health Organisation guidelines is probably the most routinely employed bed side screening tool in the country.

The Modified Lee and White (MLW) method gives a value which when performed serially gives a trend in clotting time which the investigators hypothesise to be a better tool in serially assessing the victim compared to the 20'WBCT.

The investigators propose that delayed reading of both MLW and 20'WBCT to check for clot stability at 30 minutes also provides added information in management of snake bite victims.

Envenomation by snakes is common in India. Hematotoxic bites cause the highest morbidity and mortality in Kerala, a state in the south of India.

20 minute Whole Blood Clotting Test(20'WBCT) recommended by World Health Organisation guidelines is probably the most routinely employed bed side screening tool in the country. It is the tool of choice due to its cost effectiveness in low and middle income countries (LMIC).

The reliability of 20'WBCT is questionable with respect to not just its rapidity but also its reliability. There is no standardisation for the test and procedure.

Modified Lee White (MLW) Method for coagulation is a cheap bed side test used as part of the standard treatment protocol of snake bite victims. The MLW method gives a value which when performed serially gives a trend in clotting time which the investigators hypothesise to be a better tool in serially assessing the victim compared to the World Health Organisation recommended 20'WBCT.

The investigators also propose that delayed reading of both MLW and 20'WBCT to check for clot stability also provides added information in management of snake bite victims.

The bed side coagulation test done, forms the trigger to commence antivenom in snake bite victims with hematotoxicity in resource limited settings.

Lee White (MLW) Method for coagulation is a test that has been employed for decades to assess coagulation in Jubilee Mission Hospital, Medical College and Research Institute in Thrissur for snake bite victims. It is a cheap bed side test used as part of the standard treatment protocol of snake bite victims. The MLW method gives a value which when performed serially gives a trend in clotting time which the investigators hypothesise to be a better tool in serially assessing the victim compared to the World Health Organisation recommended 20'WBCT.

The investigators also propose that delayed reading of both MLW and 20'WBCT to check for clot stability or 'clot lysis' also provides added information in management of snake bite victims.

Eligibility Criteria:
Inclusion Criteria:

1. All victims of snake bite presenting to the emergency department AND
2. Consenting to be part of the study

Exclusion Criteria:

1. Those not providing a written informed consent OR
2. Those on anticoagulants or antiplatelets OR
3. With a known hematological disorder OR
4. A known history of chronic liver disease OR
5. Received antivenom or blood products following snakebite at another centre
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia

Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of schizophrenia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.

Several lines of evidence suggest that both NMDA and oxidative stress hypotheses have been implicated in schizophrenia. Previous studies found that some NMDA-enhancing agents were able to augment efficacy of antipsychotics in the treatment of schizophrenia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of schizophrenia too. Whether a drug with antioxidant property can strengthen the efficacy of an NMDA-enhancer (NMDAE) in the treatment of schizophrenia remains unknown. Therefore, this study aims to compare NMDAE plus a drug with antioxidant property and NMDAE plus placebo in the treatment of schizophrenia. The subjects are the schizophrenia patients who remain symptomatic while having been stabilized with antipsychotic treatment. They keep their original treatment and are randomly, double-blindly assigned into two treatment groups for 12 weeks: (1) NMDAE plus Antioxidant agent (AO), or (2) NMDAE plus placebo. Clinical performances and side effects are measured at weeks 0, 2, 4, 6, 9, and 12. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests. The efficacies of NMDAE plus AO and NMDAE plus placebo will be compared.

Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
* Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial
* PANSS total score ≥ 60
* Agree to participate in the study and provide informed consent

Exclusion Criteria:

* DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
* History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study
* Clinically significant laboratory screening tests (including blood routine, biochemical tests)
* Pregnancy or lactation
* Inability to follow protocol