cyrilzakka/clinical-trials huggingface dataset:
Effect of Camel Milk With Probiotic on Type 2 Diabetes Mellitus

The purpose of this study is to investigate the effects of dietary supplement with Camel Milk containing Bifidobacterium animalis A6 on the plasma glucose and other related cytokines in patients with type 2 diabetes mellitus. 45 patients with type 2 diabetes mellitus were recruited, and a Double Blind Randomized Parallel Controlled Trial was performed. The fasting glycaemia, 2 hour postprandial glycaemia, insulin, uric acid and serum lipid (total cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol ) were measured as Primary Outcome. The Fecal microbiome, fecal metabolites, gut hormones (amylin, ghrelin, glucagon-like peptide 1, pancreatic polypeptide), inflammation cytokines (TNF-α, IL-6, MCP-1), myokines (FGF-21, irisin, osteocrin/musclin, osteonectin) and adipokines (adiponectin, resistin, lipocalin-2, adipsin) and body composition analysis were also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Age between 35\~68 years old
* Patients who diagnosed as type 2 diabetes
* Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) and antibiotic
* Agree to sign the informed consent form

Exclusion Criteria:

* Taking antibiotics or antifungal drugs within 7 days before the study
* Have serious allergic reaction to skim milk powder or milk
* Researcher are not sure whether the subjects are willing or able to complete the study
* Subject had other serious diseases
Evaluation of Use of Brain Activity Monitoring for Prediction of Migraine Attacks

This study evaluates the use of brain activity monitoring for prediction of migraine attacks in an expected time scale of 12-48 hours prior to the migraine attack.

The study will be conducted in one are. Participants diagnosed with migraine, will be evaluated for their EEG characteristics as well as daily migraine related clinical and general status. Participants' monitoring will be conducted for 20 times for a duration of one month.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with migraine by a neurologist.
* Male or Female, aged 18 -50 years.
* Able and willing to comply with all study requirements.
* Having 3-10 migraine attacks per month.

Exclusion Criteria:

* Diagnosed with chronic pain, neurological or psychiatric disorders.
* Current or past use of anti-depressants.
* A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
* History of seizures
* Head injury with consciousness loss in the last three months.
* Diagnosed as ADHD and/or use of Ritalin.
* Hearing disorder and/or known ear drum impairment.
* Having migraine attacks occurring only during the menstruation.
A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of SCULPTRA Measured by Three Dimensional Digital Surface Imaging

* Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging
* Determine the mean change from baseline in facial contour deficiency as measured by the Dermik Nasolabial Photo-numeric Scale
* Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale
* Correlate the mean volumetric change in mid-facial treatment area with the amount of product used
* Evaluate subject and investigator global assessment of improvement and subject treatment satisfaction at the end of treatment
* Obtain photographs pre- and post-treatment for the purpose of providing a subject visual aid during the course of treatment
* Collect safety data


Eligibility Criteria:
Inclusion Criteria:

* Subjects must sign a statement of informed consent.
* Subjects must be 18-75 years of age, of any race or gender.
* Female patients of childbearing potential must have a negative urine pregnancy test prior to the first treatment with the product and must use an acceptable form of birth control throughout the study (e.g., oral/systemic contraceptives, an intrauterine device (IUD) or Norplant starting at least 28 days prior to study entry and throughout the study).
* Subjects must display signs of facial contour deficiencies in the area of the nasolabial folds \[nasolabial fold scores greater than or equal to 2 (bilaterally) on the Dermik Nasolabial Photo-numeric Scale.
* Subjects must be a suitable candidate for SCULPTRA treatment.
* Subjects must be able to understand the requirements of the study and be willing to comply with the study requirements

Exclusion Criteria:

* Subjects with an allergy to any of the constituents of the product.
* Subjects with a known history of keloids or bleeding disorders.
* Subjects of childbearing potential who are pregnant, or plan to become pregnant within the study timeframe, or who are nursing.
* Subjects with significant facial hair (e.g. mustaches, beards, etc.)
* Subjects with an active inflammatory process or infection in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease in the treatment area).
* Subjects who plan to undergo major facial surgery \[e.g., rhinoplasty (with or without implant), facelift, congenital defect repair, etc.\] during the course of the study.
* Subjects who have used or plan to use exclusionary medications/treatments.
Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma

Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD)

Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone


Eligibility Criteria:
Inclusion Criteria:

* Advanced liver cancer
* No previous systemic therapy for liver cancer
* Measurable disease on CT or MRI
* ECOG 1 or less
* Child-Pugh A

Exclusion Criteria:

* Active bleeding during the last 30 days
* Known history of HIV seropositivity
* Any severe and/or uncontrolled medical conditions including

Other protocol-defined inclusion/exclusion criteria may apply
Probiotics to Improve Women's Health

The purpose of the study is explore the effect of probiotics on plasma lipopolysaccharides (LPS) concentrations, as well as insulin and glucose levels, in obese women prior to and after dietary challenges (high carbohydrate meal, high fat meal).


Eligibility Criteria:
Inclusion Criteria:

* BMI=30-40 kg/m2
* Healthy, age 18 or older
* Not consuming yogurt or cultured milk regularly (\</= 1x/wk) or any probiotic supplement

Exclusion Criteria:

* Medical conditions or medications that may affect metabolism as determined by the PI.
The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants

To determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin (HIVIG) and of zidovudine (AZT) in infants with established HIV infection; to get preliminary evidence for the effectiveness of this type of treatment in preventing the advance of disease in HIV infected infants. HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease.

HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease.

Participants are randomized to receive either oral AZT or HIVIG. Patients may receive treatment for a maximum of 48 weeks. Patients are evaluated during treatment at weeks 2, 4, and every 4 weeks thereafter. Infants who are receiving HIVIG initially are treated with the appropriate age-adjusted dose of oral AZT in addition to HIVIG if they meet clinical disease progression criteria. All participants who have completed 48 weeks of treatment or who are discontinued from treatment are followed every 3 months for an additional 48 weeks. This follow-up may be conducted over the telephone.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Recommended:
* Standard immunizations. Should repeat MMR 3 months after discontinuing study.
* Benadryl and/or aspirin.
* Pneumocystis carinii pneumonia prophylaxis.
* Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy.
* Aerosol ribavirin for short-term treatment of RSV.

Concurrent Treatment:

Allowed:

* Blood transfusion.

Patients must have the following:

* Parent or guardian available to give written informed consent.
* Protocol requires prior Institutional Review Board (IRB) approval before any subject is entered into study.

Prior Medication:

Allowed:

* Gammaglobulin, intravenous (IV) or intramuscular (IM).
* Immunoglobulin, IV (IVIG).
* Maternal antiretroviral treatment during pregnancy.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
* Presence of serious acute infection requiring parenteral treatment at time of study entry.

Concurrent Medication:

Excluded:

* Prophylaxis for oral candidiasis or otitis media or other infections.
* Immunoglobulin therapy (except single dose or for hypogammaglobulinemia).
* Ketoconazole, acyclovir, or nystatin for prophylaxis.

Patients with the following are excluded:

* Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
* Presence of serious acute infection requiring parenteral treatment at time of study entry.

Prior Medication:

Excluded:

* Antiretroviral treatment or experimental treatment within 2 weeks of entry.
Validation of the CONUT Software Tool for Screening Clinical Malnutrition in the University Hospital La Paz

Nutrition Department of University Hospital La Paz decided to implement some method of screening in our centre which allowed us to detect as many patients with malnutrition risk as possible. Due to the large size of our centre, with about 1,500 beds and the few human resources in our unit, we chose to use the CONUT system (Nutritional Control), a 100% automatic method based on analytical parameters, very easy to use, low cost and whose validity is confirmed, characteristics that fulfilled our needs. The implementation of this nutritional screening method has led to a change in the ìnutritionafi culture of our centre respect to DRM in most of our professionals: doctors and nurses and even in the management team, so all of them understand the importance of the process and know about the available tools and knowledge to indicate an adequate and early nutritional support.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* Patients older than 15 years
* Patients admitted to the General Hospital or Traumatology area
* Patients who have signed the informed consent to participate in the study
* Patients who do not meet any exclusion criteria.

Exclusion Criteria:

* Pregnant women.
* Patients whose physical and / or psychic capacity prevents them from providing all the data collected by the evaluated methods or who do not have a caregiver.
* Non-collaborating patients in data collection
* Patients in whom a hospital stay of less than 48 hours is expected.
* Patients who at the time of performing the analyzes are in the ICU and OER
A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.
* Participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).
* Participant was less than or equal to (\<=) six months postpartum.
* Participant must be amenable to intravenous therapy.

Key Exclusion Criteria:

* Active psychosis.
* Attempted suicide associated with index case of postpartum depression.
* Medical history of seizures.
* Medical history of bipolar disorder.

Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.

This is a a randomized phase II/III trial comparing salvage SBRT with standard of care (SOC) regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy.

This is a multicentric randomized seamless phase II/III study comparing SBRT to conventional RT or moderately hypofractionated RT on the prostate bed.

All subjects will be randomly assigned in a 1:1 ratio:

1. Experimental arm: Radiotherapy treatment in 5 fractions.
2. Control arm: Radiotherapy treatment within a normofractionated or mildly hypofractionated schedule. For the control arm, each participating center can choose between a normofractionated schedule (32 to 35 treatment sessions) and a moderately hypofractionated schedule (20 sessions).

Eligibility Criteria:
INCLUSION CRITERIA

1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.
2. Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng/mL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA \>0.1 ng/mL , or three consecutive PSA rises)
3. WHO PS 0-1
4. Age ≥18 years
5. Ability to understand and willingness to sign a study-specific informed consent prior to study entry
6. Ability to understand and answer the EPIC-26 form in one of the languages available

EXCLUSION CRITERIA

1. Patients with a pT4 tumor at prostatectomy
2. Patients with previously pathologically confirmed N1
3. Patients with macroscopically involved margin at surgery (R2)
4. Patients with a history of distant metastases
5. Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter \>1cm and/or positive on PSMA without other explanation, are considered as a pelvic recurrence.
6. Latest PSA \> 2ng/ml
7. Patients with a IPSS \>20
8. Gleason 10 tumor
9. Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate
10. Prior pelvic radiotherapy
11. Prior hormonal therapy started more than 6 weeks before randomization
12. History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.
13. Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.
Pulmonary Hypertension Registry Switzerland

Registry Data from PH-patients in Switzerland, who have given consent to records for research purposes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PH

Exclusion Criteria:

-
Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers

The overall aim with this project is to investigate the effect of dexmedetomidine on control of breathing in healthy volunteers and to compare it with propofol at the same degree of sedation.

15 volunteers will be investigated for their hypoxic and hypercapnic ventilatory response during sedation with dexmedetomidine and propofol in a randomized cross-over study.

6 volunteers will be investigated for their repeated response to hypoxia and hypercapnia in order to validate the method.

Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Age 18-40
3. American Society of Anesthesiologist´s classification (ASA) 1, i.e. healthy
4. No medication
5. No allergies
6. Non-smoker/no snuff, i.e. no nicotine intake
7. Normal weight, BMI \<26

Exclusion Criteria:

Snoring
Circadian Rhythm of Blood Lactate

To elucidate whether blood lactate, lipid transfer proteins and PPARs/CLOCK/Bal1 have a circadian rhythm

Blood will be drawn fasting and then every hour over a period of 24 hours in 30 healthy probands.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years old

Exclusion Criteria:

* Inability/unwilling to give written informed consent
* Chronic disease
A Trial of MBC-11 in Patients With CIBD

This study evaluates MBC-11 (a conjugate of a bone-targeting vehicle (etidronate) and a cytostatic agent \[ara-C\] in patients with malignant tumors with CIBD. This is a first use in human.

A standard "3+3" dose escalation design to determine Maximum Tolerated Dose with consecutive different dose level cohort recruitment.

The following dose levels to be investigated: 0.5 mg/kg, 1.0 mg/kg, 2.5 mg/kg, 5.0 mg/kg, 10 mg/kgm 20 mg/kg. The study for each patient consists of 14-days screening period, single dose administration of MBC-11 followed by 7-day safety monitoring and then 2 cycles of multiple use of MBC-11 (28 days each cycle, study drug is administered at Days1-5). In case of partial metabolic reaction/stable metabolic reaction therapy maybe prolonged up to 4 cycles (at investigator and sponsor consideration)

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant tumor (breast cancer, prostate cancer etc)
* Bone metastases, documented by radiographs, bone scan
* No available standard chemotherapy or no indication for chemotherapy at the time of screening
* Eastern Cooperative Oncology Group \[ECOG\] status 0-2
* Adequate bone marrow function (hemoglobin ≥ 9 g/dL with or without transfusion requirement, absolute neutrophil count ≥ 1500/mm3, and platelets ≥ 75,000/mm3)
* Adequate liver function (bilirubin ≤ 2 x Upper Limit of Normal \[ULN\], Alanine aminotransferase \[ALT\] ≤ 2.5 x ULN).
* Adequate renal function (creatinine ≤ 1.5 x ULN) and creatinine clearance ≥ 50 mL/min \[measured or calculated by nomogram\]).

Exclusion Criteria:

* Systemic chemotherapy and/or investigational therapy within the previous 4 weeks
* Fracture ≤ 6 month prior the inclusion in the study
* Brain metastasis
* Serum calcium levels \< 8.5 mg/dL (\< 2.2 mmol/L)
Circadian, Weekly and Seasonal Variability of Postoperative Mortality and Morbidity (Zirkadianest)

Mortality is subject to cyclic variability: circadian, weekly, and seasonal. This has been shown for different populations, different diseases and in different countries, but not for surgical patients. Aim of this study is therefore to investigate the association between circadian, weekly, and seasonal effects time of surgery postoperative mortality of patients undergoing surgery and general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

All Patients who underwent anesthesia within the study time period.

Exclusion Criteria:

none
Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction

Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and decreased vascular dilatation, receiving a cholesterol lowering diet were given either valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination treatment with valsartan 160 mg and fluvastatin 80 mg.


Eligibility Criteria:
Inclusion Criteria:

* Arterial hypertension
* Dyslipidemia
* Cholesterol lowering diet

Exclusion Criteria:

* Constant antihypertensive treatment
* Diabetes mellitus
* Myocardial infarction or stroke in the previous 3 months

Other inclusion and exclusion criteria may apply
Anti-stress Effect of Theanine on Students During Long-term Pharmacy Practices

Long-term practices in a hospital setting and community pharmacy might induce chronic stress in students. Alterations of salivary amylase activity will be measured in students during pharmacy practices as a marker of stress. Theanine is reported to have anti-stress effect on experimental animals under chronic stress and on humans under short-term stress. The purpose of this study is to measure stress symptoms in students during long-term pharmacy practices and to evaluate the efficacy of theanine in suppressing chronic stress, by measuring the salivary amylase activity.

The investigators have found that theanine, an amino acid in green tea, has anti-stress and anti-aging effects using experimental animals. Mice, under chronic psychosocial stress, showed shortened longevity and brain dysfunction. However, when the mice ingested theanine, they showed normal longevity and brain function even though the mice were under psychosocial stress. These data showed that theanine has a significant anti-stress effect on mice. In addition, theanine has been reported to have an anti-stress effect on humans against short-term stress by measuring salivary amylase activity. However, the efficacy of theanine against chronic stress has not been examined. Long-term pharmacy practices might induce chronic stress in students. Based on this background, the investigators designed a randomized study to evaluate the clinical efficacy of theanine ingestion in suppressing chronic stress in students during long-term pharmacy practices.

Eligibility Criteria:
Inclusion Criteria:

* Students of pharmaceutical sciences in the fifth grade, nonsmoker
* Obtained written informed consent from the student before participation
* Possible to take tablets for 16 days
* Possible to check salivary amylase activity two times daily for 10 days

Exclusion Criteria:

* Taking tranquilizer(s)
* Smoker
* Diagnosed as inadequate to participate in the study by a doctor