cyrilzakka/clinical-trials huggingface dataset:
Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

This study will investigate adjunctive pregnenolone for patients with schizophrenia and schizoaffective disorder.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: DSM-IV/DSM-IV TR schizophrenia or schizoaffective disorder;
* Gender: Males and Females;
* Age: 21-65;
* Caucasian or Non Caucasian;
* Capable of providing informed consent;
* Duration of illness equal to or greater than one year;
* No change in antipsychotic medication in the previous eight weeks, no change in antipsychotic dose in the previous four weeks;
* No benzodiazepine use in the past twelve hours prior to cognitive testing;
* The patient cohort will be enriched for cognitive symptoms (Composite BACS scores = 0-3 standard deviations below the mean, assessed at the screening visit).

Exclusion Criteria:

* Subjects with a DSM-IV/DSM-IV TR diagnosis of alcohol or substance dependence (other than nicotine) within the last month;
* Subjects with a history of significant head injury/trauma, as defined by one or more of the following:

  * Loss of consciousness (LOC) for more than 1 hour,
  * Recurring seizures resulting from the head injury,
  * Clear cognitive sequelae of the injury,
  * Cognitive rehabilitation following the injury;
* Subjects with unstable medical illness or neurological illness (seizures, CVA);
* Patients with hormone-sensitive tumors (such as breast, uterine, or prostate cancer);
* Clinically significant abnormalities in physical examination , ECG, or laboratory assessments;
* Pregnant women or women of child-bearing potential, who are either not surgically-sterile or not using appropriate methods of birth control (serum beta-human chorionic gonadotropin \[HCG\] will be performed at baseline, 4 weeks, and 8 weeks to exclude pregnancy);
* Women who are breast-feeding;
* Electroconvulsive therapy (ECT) treatment within the last 3 months;
* Use of oral contraceptives or other hormonal supplementation such as estrogen. Although early studies suggested no effects on menstrual cycle, alterations in downstream metabolites of pregnenolone (such as estradiol) could theoretically impact the efficacy of oral contraceptives and/or estrogen replacement. Similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids, resulting in hair, skin, or other steroid-related changes. Since we have determined in our prior study that pregnenolone administration does not result in downstream elevations in DHEA, DHEAS, estradiol, or testosterone, these possibilities may be unlikely;
* Current active suicidal and/or homicidal ideation, intent, or plan;
* Known allergy to study medication.
FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer

FOLFOX4 plus Avastin has been suggested as firstline regimen for advanced colorectal cancer by NCCN, a new angiogenesis inhibitor, known as Endostar(Recombinant Human Endostatin), prolonged the overall survival, time to progression and improved response rate in metastatic lung cancer in a large phase III clinical trial in china, so we design this trial to evaluate the safty and efficacy of FolFox4 plus Endostar in patients with advanced colorectal cancer

Endostar is free supported by Shangdong Simcere Medgene biotech co.,Ltd. Endostar combination with Chemotherapy has been the first line treatment regimen to advanced NSCLC. Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. China NCCN colon or rectal cancer clinical practice guideline recommends Chemotherapy plus angiogenesis inhibitor as the first line treatment scheme. So we design FOLFOX4 plus Endostar to treat advanced colorectal cancer to research the RR and safety. We believe this treatment regimen may be a new approach to the advanced colorectal cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed metastatic CRC
* Measurable disease according to Response Criteria In Solid Tumours (RECIST)
* Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
* Age 18\~75
* Life expectancy \> 3 months
* Signed informed consent (IC)
* Adequate haematological and biological functions

Exclusion Criteria:

* Pregnant or lactating women
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs
* Neuropathy, brain, or leptomeningeal involvement
* Treatment with any biologic, cytotoxic, radiation , or hormonal therapy within four weeks.
* Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
* Uncontrolled significant comorbid conditions and previous radiotherapy
Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.


Eligibility Criteria:
Inclusion Criteria:

* The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting the screening visit. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart.
* Of either sex, aged 18 years or older.
* A diagnosis of Diabetes Mellitus, Type I or II, requiring medication to control blood glucose levels.
* A qualifying ulcer, defined as follows:

  * Ulcer grade 1 or 2 on the Wagner Classification Scale (refer to Section 9.4.1)
  * Infection / inflammation grade 1 or 2 for wound bed inflammation (refer to Section 9.4.2)
  * Has not been treated or has not responded to treatment during the past 30 days
  * Has an apparent area ≥ 3.0 cm²
* Requires debridement of the wound bed
* Is sufficiently moist to allow collection of wound fluid using a filter paper disc
* Adequate arterial blood flow evidenced by ankle brachial index (ABI) of ≥ 0.7 and ≤ 1.1; if the ABI is greater than 1.1, then toe pressure of \>50 mmHg.
* Subject must be willing to use the Darco shoe off-loading device and insole, or a comparable device, as indicated.
* Subject able to follow instructions, particularly regarding the application of test articles and dressings at home. Able to apply the test articles, or has a caregiver available to apply the test articles according to the protocol.

Exclusion Criteria:

* Contraindications or known hypersensitivity to the test articles or their components.
* Cellulitis extending \>2 cm around the target ulcer, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
* Target ulcer tunneling per probing and visual assessment.
* Use of systemic antibiotics or any drug listed in Section 9.1.6 of this protocol within 10 days of SCR visit.
* Concomitant illness or condition which, in the opinion of the Principal - Investigator, places the subject at risk for this study.
* The Medical Monitor may declare any subject ineligible for a valid procedural or medical reason.
Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells

Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 40 to 75;
* Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1\<70% predicted value and FEV1/FVC \< 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination);
* Clinically stable for more than 4 weeks;
* Tolerant to bronchofiberscope;
* Written informed consent signed.

Exclusion Criteria:

* Pregnant or lactating women;
* Patients positive for syphilis, HIV;
* Patients with malignant tumor;
* Patients with serious or significant pulmonary infection and need anti-infection treatment;
* Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
* Patients with a history of abusing alcohol and illicit drug;
* Patients participated in other clinical trials in the past 3 months;
* Patients assessed as inappropriate to participate in this clinical trial by investigator.
Bacteria and Intestinal Translocation in Surgery (Bandit)

Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. Preoperatively baseline health data is collected and a skin swab and rectal swab for baseline skin and gut microbiota is taken. During the surgery additional clinical data and additional samples will be obtained. Additional samples include: rectal swab, biopsies of the resected specimen (lymph node, peritoneum, intestinal content, mucosa), venous blood sample (7.5ml) at the end of the operation, liver biopsy and skin biopsy. Postoperative health data is recorded. If a surgical site infection occurs a swab is taken too. With 16 sRNA (small ribonucleic acid) based sequencing the investigators will quantify the abundance of the different bacterial species in all samples. Primary outcome will be to assess a difference of 16sRNA signal in the liver and lymph node biopsies between patients with and patients without surgical site infection. Secondary outcomes include variables predicting the occurence of surgical site infections and a model describing the way bacteria may take to cause wound infection.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* All Ages
* All Gender
* Elective Abdominal Surgery
* Age \> 18
* All approached (laparoscopic, open)
* All ethnic and sociodemographic backgrounds
* Sufficient knowledge of the study language (German)

Exclusion Criteria:

* pregnant or lactating women
* no operation performed (i.e. only planned)
* insufficient knowledge of project language (German)
* lack of informed consent
* known colonization with multi-resistant bacteria (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or extended spectrum betalactamase (ESBL))
* known cirrhotic liver disease
Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19

The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.

The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.

Subjects that PCR is negative after having direct contact with symptomatic subjects and diagnosed with COVID-19 (PCR positive) will be randomized to receive Nitazoxanide TID or placebo TID for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent from patient or legal representative.
* Subject of both genders (male and female not pregnant and not breastfeeding) aged 18 years or over;
* Subject that lives in a vulnerable community;
* Subject that were in direct contact with confirmed cases of SARS-CoV-2 infection, as they live or work directly with index patients;
* Not showing symptoms compatible with COVID-19 and and that do not have a positive RT-PCR test in a nasopharyngeal swab sample before randomization;
* Participant capable of understanding and fulfilling all activities planned for the study;
* In use of an acceptable method of contraception throughout the study.

Exclusion Criteria:

* Participating in another RCT in the past 12 months;
* Positive PCR result for COVID-19 during screening;
* History of infection confirmed by SARS-CoV-2;
* Present symptoms suggestive of SARS-CoV-2 infection;
* Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to:

  * HIV or HTLV virus infection;
  * Chronic hepatitis C (HCV) treated with direct antiviral drugs;
  * Liver failure;
  * Severe renal failure, including dialysis;
* Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds;
* Concomitant administration of drugs that may interact with the product under study (nitazoxanide);
* Participants who underwent treatment with antivirals and / or antiparasitic drugs in the last 30 days;
* Subject in antineoplastic treatment with chemotherapy or radiation therapy;
* Subject with severe autoimmune diseases in immunosuppression;
* Transplanted participants;
* Pregnant or lactating women;
* Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.
Innervation of Human Cricopharyngeal Muscle By Recurrent Laryngeal and External Branch of Superior Laryngeal Nerve

The investigators hypothesized that, external branch of the superior laryngeal nerve (EBSLN) and/or recurrent laryngeal nerve (RLN) contribute to the motor function of the human cricopharyngeal muscle (CP). The investigators aimed to assess the contribution of the laryngeal nerves (EBSLN and RLN) to the motor activity of the cricopharyngeal muscle, during thyroidectomy with intraoperative neuromonitoring (IONM).

This study group consisted of a consecutive patients undergoing thyroid surgery with intraoperative neuromonitoring (NIM 3.0 Nerve Monitoring Systeme (Medtronic Xomed, Jacksonville, FL, USA) ) for various diseases. In all patients, each side of the neck operated was considered as a separate entity in our study.

EMG recordings were accomplished with a pair of needle electrodes inserted into the CP and mid-portion of the CT muscle that is located on the superior side of the RLN, which were plugged into the third and fourth channels of interface-connector box, respectively, at the end of the thyroidectomy or lobectomy. The investigators evaluated the innervation pattern of the CT muscle in an other study. Therefore the EBSLN is the main supplier of the CT muscle, the EMG findings of the CT muscle were used to confirm it, in this study.

EBSLN, pharyngeal plexus (PP), RLN and vagus nerve were stimulated with a monopolar stimulator probe at 1 mA. While stimulating these nerves, the ipsilateral CP muscle was visually observed for possible contractions and electromyographic recordings were obtained with the 4-channel NIM 3.0 Nerve Monitoring System.

Eligibility Criteria:
Inclusion Criteria:

* The patients who underwent thyroidectomy.

Exclusion Criteria:

* Preoperative RLN palsy
* Thyroid cancer with massive extrathyroidal extension
* Intentional nerve transection because of cancer invasion
* The assessment failure of nerve function due to the technical deficiency of the IONM equipment
Effects of Load Monitoring on Pilates Training

There has been an increasing awareness about the need to practice some physical activity, including several objectives, mainly as a preventive character. From this perspective, notice the use of the Pilates method as an instrument of therapeutic exercise for the protection and promotion of health. However, despite being popularly performed, there is still no scientific evidence on the standardization of the use of the method and its progression to an adequate prescription of physical training. The objective is monitoring the progression of loads of a 12-week training among the basic, intermediate and advanced levels of the Pilates method through heart rate (HR), subjective exertion perception (PSE) and heart rate variability (HRV). In addition, analyzing the effect of the method on cardiorespiratory and autonomic parameters. 40 healthy men aged 18-36 will receive Pilates training for 12 weeks. After the initial assessment and familiarization with the method, the training period will begin totalizing 36 sessions for three months, where each class lasts approximately 1 hour. During the three months, the participants must pass through the three levels of training: Basic, Intermediate and Advanced. During each session, the investigators will initially collect: psychological questionnaire, visual analogue pain scale (VAS), and cardiorespiratory parameters (systolic and diastolic blood pressure, HR, respiratory rate and partial oxygen saturation). Throughout the session a heart rate meter will be positioned on the chest of the participant to capture HR, which will occur every five minutes together with the PSE illustrated in the model proposed by Borg. At the end of each session, the cardiorespiratory parameters will be collected again. In addition, cardiorespiratory parameters and HRV will be analyzed at baseline and after three months of training. In the case of HRV analysis, linear methods in the time and frequency domain will be verified. For the statistical analysis of the cardiorespiratory and autonomic parameters in the pre and post training moments will be used paired t test for normal data or Wilcoxon test for non normal data. For the analysis of the training load will be used the correlation of Pearson or Sperman according to normality. The definition of cutoff points for the HRV and PSE indices will be obtained by the ROC curve.


Eligibility Criteria:
Inclusion Criteria:

* male sex
* healthy
* aged between 18 and 36 years

Exclusion Criteria:

* smokers
* alcoholics
* use drugs that influenced cardiac autonomic activity
* cardiovascular, metabolic or endocrine diseases.
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study

Despite recent advances in the understanding and treatment of schizophrenia, this devastating disease still affects one percent of world's population. Existing antipsychotics reduce psychotic symptoms but are generally not very effective in treating so called negative symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the disease. Furthermore, a significant portion of patients is refractory to all current treatments. Therefore new treatment strategies are needed.

Several studies suggest a strong association between schizophrenia and the endocannabinoid system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient - cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one of the most effective modern antipsychotics, amisulpride, but it induced significantly less side effects.

In this phase I safety study, the investigators will evaluate the pharmacokinetics, pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new tablet pharmaceutical preparation of cannabidiol in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent given by the subject
* Both, female and male subjects may participate
* Age between 18 and 45
* Negative drug screening at the time of screening
* Non-smoking
* In female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1.
* Body Mass Index between 18 and 30

Exclusion Criteria:

* Lack of accountability
* Any current psychiatric disorder through the Structured Clinical Interview for DSM-IV (SCID) at the time of screening
* Pregnancy or lactation phase in female at the time of screening
* Any known psychiatric or neurological illness in the participant's history.
* Known family history concerning psychiatric disorders
* Relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year)
* Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
* Consumption of any illicit drugs (except cannabis in history, see above)
Study to Investigate Multiple Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects

1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after multiple oral doses.
2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves your body and how your body acts on the study drug) of AZD5213 in your blood and urine.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-fertile female healthy volunteers aged 18-50 years and 65-80 years inclusive at day of enrollment with suitable veins for cannulation or repeated venipuncture.
* Male healthy volunteers should be willing to use barrier contraception during sexual intercourse, ie condoms, even if partner is using contraceptive method, from the first day of dosing until 3 months after the last dosing with AZD5213.
* Body weight of ≥50 to ≤100 Kg and Body Mass Index (BMI) ≥18 to ≤30 kg/m2.

Exclusion Criteria:

* History and presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disorders.
* History or presence of gastrointestinal (including irritable bowel disease), hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. Surgery on gastrointestinal tract.
* History of previous or ongoing psychiatric disorders.
Protein Before Night Sleep to Improve Recovery and Performance in Runners

32 runners will be randomized into two groups. The duration of the intervention is one week including a strenuous endurance training program. Group 1 receive a protein beverage before each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test before and after the intervention and blood sampling before and during the intervention to check for markers for muscle damage.


Eligibility Criteria:
Inclusion Criteria: VO2max \>55 ml O2/kg/min -

Exclusion Criteria:women, smokers

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