cyrilzakka/clinical-trials huggingface dataset:
Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors

This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin


Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, or for whom no standard therapy exists, or who might benefit from treatment with carboplatin
* A minimum of 4 weeks since the last treatment with chemotherapy
* WHO Performance Status 0 (able to carry out all normal activity without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work)
* Age ≥ 18
* Adequate hematological parameters
* No major impairment of renal or hepatic function
* Written informed consent obtained

Exclusion criteria:

* Major surgery less than 4 weeks prior to study entry and/or not fully recovered from surgery
* Chemotherapy or investigational compound less than 4 weeks prior to study entry, or planned while participating in the study
* Prior administration of an epothilone
* Hypersensitivity to carboplatin. Patients resistant to carboplatin are not recommended to enter the trial
* Radiotherapy (RT) less than 4 weeks prior to study entry (except for palliative therapy of distant metastases), or planned RT while participating in the study
* Diarrhea within 7 days prior to start of treatment. Unresolved bowel obstruction
* Peripheral neuropathy \> Grade 1 (mild)
* Symptomatic brain metastases
* Colostomy

Other protocol-defined inclusion/exclusion criteria may apply
IV Cocaine Abuse: A Laboratory Model - 4

The purpose of this study is to evaluate the effects of pergolide on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving in non-opiate dependent cocaine users.


Eligibility Criteria:
Please contact site for information.
Safety, Tolerability, and Pharmacokinetics (PK) of CTP-499

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CTP-499 following single dose administration.

This is a double-blind, single ascending dose administration study of four doses of CTP-499. Following dosing safety and tolerability will be assessed. Blood and urine samples will be taken for pharmacokinetics (PK) and bioavailability. Safety assessments will include monitoring of adverse events, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead ECGs, and physical examination findings.

The plasma concentration time data for CTP-499 and its metabolites will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analysis. The primary pharmacokinetics parameters are: Cmax, Tmax, T1/2, AUClast and AUCinf for plasma; relative bioavailability; and Ae and CLr for urine.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* ages 18 to 55 years old
* nonsmokers
* BMI of 18 to 30 kg/m2

Exclusion Criteria:

* Significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders of drug hypersensitivity
* Systolic Blood pressure \< 90 or \> 140, diastolic bp \> 90
Efficacy and Safety of tACS for Depression: a Multicenter RCT Study

Transcranial alternating current stimulation (tACS) is a promising non-invasive technique for major depression, because of its advantage of lower risks and expenses compared to other therapies such as deep brain stimulation, electroconvulsive therapy, and repetitive transcranial magnetic stimulation. Randomized controlled trials (RCTs) of depression treated by tACS have been conducted but provided limited and incongruous results. We designed a multi-center RCT to evaluate the efficacy and safety of tACS for depression.

Eligible participants will be patients diagnosed with depression (HDRS-17≥8), aged 18 to 65, and without other conditions that could interfere with the study. A total of 72 participants will be recruited from 4 clinic centers. Participants will be randomized 1:1 to active tACS or sham stimulation group. The study staff and the participants are blinded to the randomization results. Stimulating electrodes will be placed on the scalp corresponding to bilateral dorsolateral prefrontal cortex (DLPFC) using frequency of 10Hz and amplitude of 1.5 to 2.0 mA. The intervention will last for 4 weeks, containing 20 40-minute sessions in total. Another 4-week observation will be followed by the end of the intervention. Participants will receive assessments at baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks after the study begins. Psychological scales are used for the evaluation of their mental and quality of life. Besides, electroencephalogram (EEG) recording and magnetic resonance imaging (MRI) scans will also be performed to quantitatively measure the neural activities as well as the functional connectivity changes within the depression-related circuits.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of depressive disorder;
2. Age ranges between 18 and 65 years;
3. HDRS-17 score equals to or above 8;
4. No medical history/Under stable antidepressant treatment in one month;

Exclusion Criteria:

1. Combination of other psychotic disorders and neurological diseases;
2. History of invasive brain surgeries;
3. Non-invasive neurostimulation treatments within 3 months;
4. Physical condition that may endanger patients' safety during the study.
Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus

This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).


Eligibility Criteria:
Inclusion Criteria:

* Serological evidence of chronic hepatitis C infection by anti-hepatitis C virus (HCV) test
* Detectable HCV-ribonucleic acid (RNA) plasma level testing by Roche AMPLICOR HCV (\<50 International Units per milliliter \[IU/mL\]) (qualitative test)
* Chronic liver disease consistent with infection of CHC
* Compensated liver disease (Child-Pugh Grade A)
* Serological evidence of infection by HIV-1 test, anti-HIV-1 or HIV-1 RNA detection
* Negative pregnancy urine or blood test (for women in childbearing age); additionally, all men and women of childbearing potential must agree to use two effective forms of contraception during the treatment and during the 6 months after the end of treatment

Exclusion Criteria:

* Pregnant or nursing women and male partners of pregnant women
* Prior therapy with interferon (IFN) or ribavirin and any investigational medication less than or equal to (\</=) 6 weeks before the first dose of the study drug
* History or other evidence of a medical condition associated with chronic liver disease further than HCV
* Active opportunistic infection associated with HIV and / or cancer requiring systemic therapy
* History of any other significant illness which in the investigator's opinion, could result in the participant's inability to meet the Protocol requirements
Lollipop on Gastric Emptying

To investigate the effect of chewing lollipop on gastric volume and gastric emptying in healthy volunteers drinking water.


Eligibility Criteria:
Inclusion Criteria:

* volunteer aged 18 years-45 years old
* volunteer with a body mass index between 18 and 28 kg/m2

Exclusion Criteria:

* those with history of diabetes mellitus
* those with gastric diseases
* those with history of gastro-intestinal surgery
* those with history of smoking
* those with use of gastric mobility medicines
* those with pregnancy or breeding
Database Surveillance Safety Study of PENTACEL® Vaccine

The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.

The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization.

Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.

Eligibility Criteria:
Inclusion Criteria:

* Receipt of DTaP vaccine during the study period by a previously unvaccinated child

Exclusion Criteria:

* None
Brain Networks Implicated in Lifelong Premature Ejaculation Patients

Using Brain Mapping and Cognitive ERPs, the investigatos have searched for a Brain Networks involved during Inhibitory Control in Lifelong Premature Ejaculation (LPE) participants. The investigators have designed a clinical trial comparing placebo with tDCS and blacebo group against Dapoxetine, studying the effects on LPE, as well as side effects and their medium and long-term duration.

Lifelong premature ejaculation (LPE) is a very common male sexual dysfunction like erectile dysfunction. It produces great distress to sexual harmony and even fertility. Previous neurophysiology studies revealed an ejaculation-related control mechanism in the brain: left inferior frontal gyrus (IFG) activation during successful inhibition. If we use the left IFG as a seed, participants showed weaker resting-state functional connectivity (FC) activity, between the seed and two areas (left dentate nucleus (DN) and right frontal pole) compared with controls.

The main goal is to compare whether the brain biomarker only exists in participants with LPD and how it responds to treatment with Dapoxetine and with tDCS against the IFG networks and lDN, measuring the connectivity changes in these brain networks and FC.

Eligibility Criteria:
Inclusion Criteria:

* To be over 18 years old and less than 70 years
* Best-practice diagnosed Longlife Premature ejaculation
* Diagnosed since at least one years prior to enrollment.
* No use drugs or medicines

Exclusion Criteria:

* Serious visual and hearing loss
* Brain injury following cranial trauma
* Other neurological disorders like Parkinson, ME, headache, etc.
* Birth trauma
* Mental retardation
Formulas for Diabetes With Sucromalt & Isomaltulose on Glycemic Index, Hormones & Subjective Appetite in Type 2 Diabetes

Consumption of nutritional supplements with low glycemic carbohydrates induce favorable glycemic responses in subjects with type 2 diabetes. The aim of this study was to compare the effect of the intake of specific formulas for diabetes, with different types of carbohydrates (isomaltulose and sucromaltose) on the glycemic response, release of intestinal peptides and subjective appetite in Type 2 diabetic individuals. In a randomized, double-blind, cross-over study of 4 treatments, 16 subjects (56.60 ± 1.11 years). Fasting blood samples were taking, after that they were given to consume formula or reference product assigned randomly. Subsequently, samples of capillary and venous blood were obtained at times 30, 60, 90, 120 and 180 min, after the start of consumption of the experimental beverage for the measurement of glucose, insulin, gastric inhibitory peptide (GIP) and glucagon-like peptide-1 (GLP-1). The assessment of subjective appetite was measured by Visual Analogue Scale (VAS).

This was a randomized, double-blind, cross-over study of 4 treatments that was conducted according to the Good Clinical Practice Guidelines, with all applicable Food and Drug privacy regulations, and ethical principles based on the Declaration of Helsinki. Participants signed informed consent, approved by the Human Research Ethics Committee of the Endocrine-Metabolic Research Center of the University of Zulia, in Venezuela. All selected subjects attended a first visit, in order to determine if they met the inclusion criteria, those who gathered them, were subjected to four consumption tests to determine the glycemic index (GI) and glycemic load (GL) and 3 consumption tests for the evaluation of subjective appetite. Each treatment or consumption session was carried out on different days.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Demonstrated use of oral hypoglycemic agents (metformin), for at least two months
* BMI of 18.5 kg/m2 to ≤ 35 kg/m2

Exclusion Criteria:

* Type 1 Diabetes
* Diabetic ketoacidosis
* Congestive heart failure
* Gastric, renal or hepatic diseases
* Myocardial infarction
* Stroke
* Subjects with insulin therapy, antibiotic therapy or corticosteroids
* End-stage organ failure
* Individuals with organ transplantation
* Coagulation or bleeding disorder
* Infectious or chronic contagious disease (such as tuberculosis, hepatitis B or C or HIV).
Impact of the COVID-19 Pandemic on Mental Health Service Utilization in Children and Adolescents

Mental health consequences of the COVID-19 pandemic may be vast and may potentially overwhelm the mental health system in a long-lasting manner. Evaluating the effects of the COVID-19 pandemic on mental health in vulnerable groups such as children and adolescents has become an immediate priority. The aim of this study is to evaluate the impact of COVID-19 pandemic on use of mental health resources namely 1) prescriptions of psychotropic medications and 2) mental health-related outpatient visits, hospitalizations and emergency department visits in children and adolescents in France. Secondary aim is to evaluate the impact of the pandemic on episodes of fatal and non-fatal self-harm episodes in the same population. This will be a population-based cohort study using data from healthcare claims, administrative medical and outpatient drug dispensation databases in France between January 1, 2016 and June 1, 2021. Findings will inform on the risk of upcoming outbreaks of mental disorders that can result in significant morbidity and mortality and guide timely targeted actions to improve mental health outcomes and wellbeing in the youngest.

Mental health consequences of the COVID-19 pandemic may be vast and may potentially overwhelm the mental health system in a long-lasting manner. Evaluating the effects of the COVID-19 pandemic on mental health in vulnerable groups such as children and adolescents has become an immediate priority. The aim of this study is to evaluate the impact of COVID-19 pandemic on use of mental health resources namely 1) prescriptions of psychotropic medications and 2) mental health-related outpatient visits, hospitalizations and emergency department visits in children and adolescents in France. Secondary aim is to evaluate the impact of the pandemic on episodes of fatal and non-fatal self-harm episodes in the same population. This will be a population-based cohort study using data from healthcare claims, administrative medical and outpatient drug dispensation databases in France between January 1, 2016 and June 1, 2021. Findings will inform on the risk of upcoming outbreaks of mental disorders that can result in significant morbidity and mortality and guide timely targeted actions to improve mental health outcomes and wellbeing in the youngest.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged from 6 to 18 years
* One dispensation of psychotropic medication or
* One mental-health related hospitalization or
* One reimbursement for an outpatient mental-health related consultation or
* One eligibility to long-term diseases corresponding to long term psychiatric diseases or
* One mental-health related cause of death using ICD-10 codes

Exclusion Criteria:

* none
Effectiveness Of MM & Kinesotaping In The Female Patients Of KO To Improve Pain & Functional Mobility RCT

to find out the Effectiveness Of Mobilization With Movement And Kinesotaping In The Female Patients Of Knee Osteoarthritis To Improve Pain And Functional Mobility


Eligibility Criteria:
Inclusion Criteria:

* · Female patients of age ranging from age above 50 years suffering from knee Osteoarthritis will be included

Exclusion Criteria:

* · Patients suffering from any type of Cancer effecting area at which treatment will be applied.

  * Patients having joint replacement or knee disease effecting the performance.
  * Having skin allergies to taping.
LAM Pilot Study With Imatinib Mesylate

This is a phase 1 clinical trial comparing imatinib mesylate to placebo for individuals with lymphangioleiomyomatosis (LAM).

This is a double blind, adjusted parallel design, randomized clinical trial comparing imatinib mesylate 400 mg daily or matching placebo on the primary outcome of log transformed serum VEGF-D level in patients with LAM.

Sirolimus using patients will have co-administration of Imatinib mesylate or placebo for 28 days prior to sirolimus discontinuation.

The duration of 400 mg imatinib mesylate or placebo will be 56 days, a dose reduction is allowed for toxicity.

The primary endpoint will be the change in the log transformed VEGF-D one month after monotherapy imatinib mesylate or placebo.

Total trial duration is 2 months of drug administration.

Eligibility Criteria:
Inclusion Criteria:

* Definite or Probable LAM
* FVC or Postbronchodilator FEV1 \<90% predicted

Exclusion Criteria:

* Current or planned pregnancy or lactation
* Unwillingness to discontinue sirolimus
* Change in the dose or use of sirolimus within the past month
* Inability to perform spirometry
* Allergy or intolerance of albuterol and/or ipratropium
* Other serious illness that would impact the outcome of the study including cancer that has not received curative therapy, Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study), uncontrolled diabetes, chronic renal disease, chronic liver disease, or active uncontrolled infection
* Current lung transplant
* Known diagnosis of human immunodeficiency virus (HIV) infection
* Current cigarette smoking
* Required use of warfarin, ketoconazole, itraconazole, clarithromycin, or rifampin during the 2 months of the study.
* Unwillingness to avoid grapefruit juice or St. Johns Wort during the study.
* Planned surgery during the 2 months of the study.
* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
* Patient has received and other investigational agents within 28 days of first day of study drug dosing.
Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with \< 34 0/7 weeks of gestation.
* Individuals with severe preeclampsia or HELLP features.

Exclusion Criteria:

* Pregnant female patients presenting with disseminated intravascular coagulopathy (DIC).
* Individuals with non-reassuring fetal status requiring delivery, non-viable fetuses, previable pregnancy (\<23 0/7 weeks gestation), stroke, in utero fetal demise, known atypical hemolytic uremic syndrome, familial or acquired thrombocytopenia purpura, paroxysmal nocturnal hemoglobinuria, allergy to Ravulizumab, inability or unwillingness to sign informed consent.
Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).

Throughout the COVID-19 pandemic, reduced access to childcare, money- and health-related worries and extended confinement and social isolation have placed great pressure on many families. There is evidence that many parents in the UK have struggled to manage their children's behaviour. For instance, Co-SPACE, an ongoing UK-wide study led by the University of Oxford, found a significant increase in parents reporting behavioural problems in children and an increase in family-related stress in response to various local and national lockdowns. Co-SPACE has also found up to 70% of parents reported wanting additional support.

The SPARKLE (Supporting Parents and Kids through Lockdown Experiences) study aims to address this pressing need. SPARKLE is a rapid-deployment randomised controlled trial evaluating whether a digital public health parenting intervention can help parents to manage their children's behaviour problems, as impacted by the COVID-19 UK pandemic and lockdowns.

We aim to evaluate whether the negative effects of the pandemic can by reversed by providing parenting advice digitally, using a specially-designed app, Parent Positive. The Parent Positive app will provide advice to parents through animations, delivering messages carefully selected by parents and experts in the field. The messages will be supplemented with practical parenting resources and an opportunity to network with other parents for peer support. The animations are light-hearted, humorous and non-judgmental and are delivered by eight high-profile celebrities who are also parents.

The SPARKLE study will involve 616 Co-SPACE parents, half of whom will receive access to the Parent Positive app and half who won't.


Eligibility Criteria:
Inclusion Criteria:

* The Co-SPACE inclusion criteria will apply: participant is willing and able to give informed consent, must be at least 18 years old and lives in the UK.
* SPARKLE-specific criteria will be: participant (parent/caregiver) has a child aged 4-10 years and has access to a smartphone or tablet with operating system OS 8-9 or higher (Android devices) or iOS 12-13 or higher (Apple devices).

Exclusion Criteria:

* There will be no exclusion criteria. Participants will not be selected on the basis of pre-existing child conduct problems.