cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness Study of a Closed Loop System Maintaining Patients' Glucose Levels During an Overnight Period

Currently, patients diagnosed with type 1 diabetes rely on either finger stick or sensor glucose readings when making their insulin dosage decisions. Designing a computerized system that mimics the way insulin is produced naturally in a person who does not have type 1 diabetes holds many challenges; all of which cannot be addressed in just one study. The purpose of the Medtronic Overnight Closed Loop study is to assess the performance of a system designed to automatically infuse the correct insulin dose during the hours that the patient is sleeping.

The system consists of an insulin pump that provides insulin to the patient through an infusion set. A sensor inserted just under the patient's skin measures glucose levels and a transmitter sends this information to the pump. To enable the sensor to register the glucose information correctly, it must be set (calibrated) by a finger stick blood glucose 3-4 times a day. In the commercially released system, the physician would recommend the continuous background (basal) insulin rates and the patient would be required to make decisions regarding extra insulin (bolus) for meals or as a response to high glucose levels.

In the Closed Loop System, a mobile control system is added to these devices. This consists of an Android phone, a closed loop algorithm and a translator. This system is designed to translate the sensor information and direct the pump to provide the required dosage of insulin automatically without requiring input from the patient.

Reliable calibration has proved challenging, and so it is important that the system function safely, even when calibration is inaccurate. In this study, a calibration error will be introduced under very controlled circumstances. This testing will identify if the system can maintain acceptable overnight glucose levels, regardless of whether or not calibration is ideal.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
* Weight is between 50 and 120 kg
* Subject has used a Medtronic insulin pump for at least the previous 6 months
* Subject has an glycated hemoglobin (A1C) value ≤ 9.0% demonstrated at the time of enrollment
* Subject uses a rapid-acting analogue insulin in his/her pump

Exclusion Criteria:

* Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
* Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
* Subject has an exclusionary cardiac disorder
Neocate In Infants and Children With Complex Conditions

Infants and young children up to 10 years of age with a complex condition involving the gastrointestinal tract are at risk of poor nutritional status, including faltering growth. Due to the complex condition, standard nutrition is often not tolerated and causes gastrointestinal symptoms.

Formulas in which protein is replaced by its smallest elements, amino acids are easier for the body to digest and absorb. These formulas might be tolerated better and reduce gastrointestinal symptoms in infants and young children with complex conditions.

The objectives of the present, exploratory study are to gain clinical evidence related to the nutritional status and gastrointestinal tolerance in infants and young children with complex conditions receiving Neocate as their primary source of nutrition. Additional objectives are to describe the nutritional and pharmacological management of these infants and young children. Study duration for each participant will be 52 weeks at maximum.


Eligibility Criteria:
Inclusion Criteria:

* Infants and young children aged from 0 up to and including 10 years of age.
* Severe impairment of at least 1 organ system
* Impairment of the gastrointestinal tract, i.e. gastrointestinal disease, congenital abnormality, surgical resection, or gastrointestinal dysfunction (including symptoms of gastrointestinal dysmotility or malabsorption).
* Receiving at least 75% of their energy intake from Neocate (Neocate Infant or Junior powdered (marketed) product) at the time of study entry (V1).
* Expected to receive at least 75% of their energy intake from the study product for at least 4 weeks from study entry (V1).
* Written informed consent provided by parents/guardians and assent by the child, if applicable, according to local law.

Exclusion Criteria:

* Infants born with a gestational age \<37 weeks that are \<40 weeks corrected age at the time of study entry (V1).
* Infants or children with endoscopically confirmed eosinophilic oesophagitis and prescribed an amino acid-based formula only for the management of the eosinophilic oesophagitis.
* Infants or children with a medical diagnosis that includes only (suspected) cow's milk allergy and/or multiple food allergy.
* Infants or children with renal dysfunction, e.g. acute or chronic kidney failure or kidney cancer.
* Infants or children with thyroid disorder or parathyroid disorder.
* Expected to receive parenteral nutrition during intervention from study entry (V1).
* Participation in any other studies involving investigational or marketed products concomitantly or within 1 month prior to study entry (V1).
* Investigator's uncertainty about the willingness or ability of the parents/guardians to comply with the protocol requirements.
A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women

The purpose of this research study is to learn about sexual function in postmenopausal women and to determine whether the use of topical clitoral application of estradiol improves women's libido, arousal, and orgasmic ability.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active postmenopausal women of any age with complaint of vulvar and/or vaginal atrophy who also complain of bothersome decreased libido, and/or arousal, and/or orgasmic dysfunction

Exclusion Criteria:

* Not sexually active with a partner or an arousal device
* Uncontrolled diabetes as defined by having a consistent blood sugar level of over 100 mg/dL
* Uncontrolled hypertension as defined by an average systolic blood pressure ≥140 mmHg or an average diastolic blood pressure ≥90 mmHg, among those with hypertension
* Allergic to estradiol
* Contraindications to estradiol such as undiagnosed abnormal genital bleeding; known/suspected or history of breast cancer; known/suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism; active or recent stroke or myocardial infarction; liver dysfunction or disease
* Spanish speaking
Effect of PATient Education Related to CV Risk factOrs in Type 2 Diabetes Mellitus(Patrol).

This study will address the proportion of achievement patients in treatment target goal on glycemic control, hypertension and hyperlipidemia according to ADA 2008 guideline, among outpatients coming to the Korean primary care nationwide.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had been diagnosed with type II diabetes mellitus
* Patients with hypertension and / or hyperlipidemia
* Patients who had agreed to Informed

Exclusion Criteria:

* Patients who had been diagnosed with type I diabetes mellitus
* Patients with neither hypertension and hyperlipidemia
Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer

The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy exceeds 3 months
* The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.

Exclusion Criteria:

* small cell lung cancer or small cell lung cancer
* Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
* Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);
Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers

We will investigate the safety and pharmacokinetics of melatonin, when administered rectally, intravesically, vaginally and transdermally. We will recruit 10 healthy female volunteers. The volunteers will have melatonin administered over 5 days; intravenously, rectally, intravesically, vaginally and transdermally. The participants will be followed for 24-48 hours with blood samples and questions about adverse events. There will be a wash-out between each session of a minimum of 7 days.


Eligibility Criteria:
Inclusion criteria:

* Healthy female
* 20-40 years old
* BMI 18-30

Exclusion criteria:

* Inability to understand Danish, written or spoken.
* Current use of melatonin or other hypnotics/sedatives
* Current pregnancy (a positive urine-HCG; the subjects will be tested prior to each study session)
* Breast feeding
* Current alcohol or drug abuse (defined as over 5 units of alcohol per day, or any usage of illegal drugs)
* Mental illness (defined as being in medical treatment)
* Serious comorbidity (American Society of Anesthesiologists (ASA) physical status 3-4)
* Participation in other clinical trials less than 1 month prior to current study
* Night-shift work within the last 14 days prior to study
* Planned night-shift work within the study period
* Known and diagnosed sleep-disorder (defined as being in current medical treatment)
* Plasma hemoglobin \<7.8 mmol/L (measured when screening participants)
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer

The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented.


Eligibility Criteria:
Inclusion Criteria:

* Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3
* ASA 2 or less
* Age 18 years or more
* No prior radio- or chemotherapy conflicting with the treatment of gastric cancer
* Haematology/Renal function/Liver function within designated range
* Patient's consent form obtained, signed and dated before beginning specific protocol procedures
* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* before patient registration/randomization, written informed consent must be given according to GCP, WMO and local regulations.

Exclusion Criteria:

* Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer
* Other current serious illness or medical conditions
* Severe cardiac illness (NYHA class III-IV)
* Significant neurologic or psychiatric disorders
* Uncontrolled infections
* Active DIC
* Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
* Known hypersensitivity to docetaxel (or any drug formulated with Polysorbate-80), or cisplatin or capecitabine or 5-FU
* Definite contraindications for the use of corticosteroids
* Use of immunosuppressive or antiviral drugs
* Any other experimental drugs within a 4-week period prior to start of neoadjuvant chemotherapy and throughout the study period
* Pregnant or lactating women
* Patients with reproductive potential not implementing adequate contraceptive measures
Intervention Program to Address PTSD in People Living With HIV

The goal of this randomised controlled trial is to evaluate the efficacy of an integrated intervention program on post-traumatic stress disorder (PTSD) symptoms and related physiological and psychological indicators of people living with HIV (PLWH). The main question it aims to answer are:

* to evaluate the efficacy of the intervention program on PTSD symptoms and related physiological and psychological indicators of PLWH through empirical research.
* to analyze the mechanism of the intervention. Eligible PLWH were recruited and randomly divided as intervention group and control group. The efficacy of Trauma Resiliency Mindfulness-Informed Intervention on PTSD symptoms and related physiological and psychological indicators in PLWH was evaluated at baseline, after intervention, and 3 months after intervention through this randomized controlled trial.

Researchers compared the intervention group and control group to see if it was feasible and had potential clinical value to introduce the Trauma Resiliency Mindfulness-Informed intervention program into the management of PLWH in China.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* been diagnosed with HIV for more than 1 month
* screened positive with PTSD CheckList - Civilian Version (PCL-C)
* voluntary participation

Exclusion Criteria:

* impaired Verbal Communication
* have received psychological treatment or related psychological intervention in the past three months
Isolation and Characterization of Mammary Stem Cells

Background:

* Cancer stem cells in breast cancer have been identified as a small population of tumor cells whose self-renewal mechanism is highly deregulated. This deregulation seems to be necessary for cancer to develop.
* These cells can be identified by certain surface markers that overlap with markers associated with normal embryonic stem cells.

Objective: To isolate tumor stem cells using the same methods generally used to isolate human embryonic stem cells.

Eligibility:

* Tissue samples will be obtained from the human cooperative network.
* Samples will include normal tissues from individuals who have no opportunistic diseases and from individuals with cancer.

Design: Breast cancer stem cells will be isolated, grown in the laboratory and characterized.

Cancers are composed of heterogeneous populations of cells with varying degrees of proliferative capacity and ability to reconstitute tumors when transplanted into nude or SCID mice.

Recently, cancer stem cells have been identified as a small population of tumor cells which possess the stem cell properties in that their self-renewal pathway is highly deregulated. This deregulation seems to be the prerequisite for the development of cancer.

Eligibility Criteria:
* INCLUSION CRITERIA:

The tissue samples will come from the human cooperative network. They have their own set of criteria. We are requesting tissue samples from individuals that are normal as well as those who have cancer.

EXCLUSION CRITERIA:

The tissue samples will come from the human cooperative tissue network and we are asking for normal samples from individuals who don't have any opportunistic diseases.
PREFerred Neurostimulation MODdalities - PREFMOD Study

This is a prospective 3x3 crossover study with randomized treatment order, comparing the short-term efficacy of conventional-spinal cord stimulation (CON-SCS) with subcutaneous stimulatio, high frequency-spinal cord stimulation (HF-SCS), and Combination Therapy, in patients with chronic intractable back pain (with or without leg pain).

Patients will be preselected for inclusion in this study at the pain management center of Neurocenter of Southern Switzerland, Ente Ospedaliero Cantonale (EOC) Lugano, and will be informed about study-details by a study clinician. After informed consent signature, the participants with chronic intractable back or back and leg pain will be implanted with the stimulation lead(s). The leads are initially connected to an external trial neurostimulator. Patients will be implanted with two epidural leads and two subcutaneous leads. A three weeks trial phase will follow. The first two days after the leads implant will be without stimulation and thereafter alternating stimulation every week will start, randomly ordering the treatments using a Williams design balanced for first-order carryover effects (i.e. incorporating 6 different treatment orders), from:

* 1) CON-SCS with Subcutaneous stimulation
* 2) HF-SCS
* 3) Combination Therapy A patient's favored SCS mode, providing that there is at least 50% reduction in pain intensity on the NRS in the trial phase, will then be implanted and patients will be followed up for 12 months.

Pain intensity and pain medication will be assessed with a pain diary at baseline and during the trial phase and will be furthermore measured after 3, 6, and 12 months after the implantation. Physical functioning, Pain Extent, Patient Global Impression of Change (PGIC), and Satisfaction with stimulation treatment (SST) will be assessed during the trial phase and will be furthermore measured after 3, 6, and 12 months after the Implantable Nerve Stimulator (INS) implantation. The other secondary outcomes will be measured at baseline, and after 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at inclusion
* chronic, intractable back or back and leg pain during at least 6 months
* pain intensity of ≥ 5 on a NRS (ranging from 0 to 10)
* previous drug therapy unsuccessful

Exclusion Criteria:

* Psychological disorders
* Coagulation disorders
* Known immune-deficiency
Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)

This study is to evaluate the safety and efficacy of the study drug compared to placebo in the treatment of cognitive impairment in men with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male between 21 and 55 years of age
* Duration of the illness must be longer than 1 year
* Patient's current antipsychotic medication regimen must be stable
* Patient is negative for selected drugs of abuse at Screening
* Must be in a stable living arrangement for at least 3 months prior to screening (not a homeless shelter)

Exclusion Criteria:

* Patient has mental retardation
* Undergone Electroconvulsive Therapy (ECT) treatment within 6 months prior to screening
* Has suicidal attempts or ideation within the last 12 months
* Patient has a history of alcohol/drug dependence within 1 year or alcohol/drug abuse within 12 months of starting the study
Association Between a Multi-Gene Panel and Renal Denervation Effectiveness in Patients With Hypertension

The purpose of this study is to assess the effectiveness of a multi-gene panel to determine which subjects are likely to respond to renal denervation therapy with Medtronic's Symplicity Spyral™ multi-electrode renal denervation system.

The objective of this study is to assess if renal denervation (RDN) effectiveness using the Symplicity SpyralTM multi-electrode renal denervation system is associated with ranked genomic scoring from the Geneticure multi-gene algorithm for renal denervation. The present study will assess if subjects who have a high genetic score, based on the hypothesized importance of the organ systems involved, will have differential responsiveness to RDN in a descending order. The genetic scoring is collectively ranked in a specific order, in that:

* Subjects with a "high level of general functionality" (functionality in the sympathetic nervous system (SNS), cardiac, vascular (renin-angiotensin-aldosterone system (RAAS)), and renal system genotypes will be most responsive to RDN.
* Subjects with high number of functional genotypes of SNS, cardiac, and RAAS will be the next most responsive group.
* Subjects with functionality in genotypes of SNS and cardiac systems will demonstrate the next most responsive group.
* Subjects with functionality in the SNS genotypes will demonstrate some degree of responsiveness.
* Subjects with functionality in the renal system, but not SNS, cardiac, nor RAAS, will be the least responsive to this therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Individual is currently or has previously been enrolled in a Medtronic clinical study utilizing the Symplicity Spyral™ multi-electrode renal denervation system.
2. Subject received Renal Denervation.
3. Subject has met the primary efficacy endpoint for the Medtronic Symplicity Spyral study and which arm they were randomized to.
4. Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

* Unable to provide written, informed, consent
Rehabilitation for Functional Memory Symptoms After Concussion

This study aims to evaluate the feasibility of novel cognitive behavioural therapy (CBT)-based intervention designed to improve functional memory symptoms after concussion. Participants will be randomized to CBT or an attention-matched control intervention (cognitive rehabilitation). The primary outcomes for this trial are feasibility metrics, including recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention.

Background: Although objectively measurable memory impairments typically resolve within weeks after sustaining a concussion, many people continue to perceive memory problems one year later. There are no known effective treatments for this condition. A promising new approach may be to target psychological mechanisms that perpetuate excessively negative perceptions of memory ability.

Methods: A pilot randomized controlled trial to evaluate the feasibility of a new cognitive behavioural therapy (CBT)-based treatment program specifically designed to improve persistent memory complaints after concussion. The main inclusion criteria will be (i) concussion in the past 6 to 24 months, (ii) research diagnosis of Functional Cognitive Disorder. Participants will be randomized (1:1) into one of two groups: CBT or cognitive rehabilitation. Individuals in both groups will participate in 11 x 50-minute sessions delivered over Zoom videoconference, co-facilitated by clinical psychology graduate students under the supervision of a registered clinical psychologist.

Aims: To evaluate the feasibility and potential efficacy of CBT for functional memory symptoms after concussion.

Approach: Prespecified feasibility criteria on recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention will determine the success of the pilot trial. The investigators further hypothesize that CBT will be associated with greater reductions in memory concern compared to the control intervention.

Implications: The results of this pilot study will inform a larger, more definitive clinical trial focused on testing efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old
* Fluent in English
* Have regular access to the internet
* Sustained a concussion according to the World Health Organization Neurotrauma Task Force definition between 6 and 24 months ago
* Meet diagnostic criteria for Functional Cognitive Disorder

Exclusion Criteria:

* Performance validity test failure
* Unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.),
* Unstable severe/mental illness (e.g., schizophrenia requiring hospital admission in the past year)
* Probable alcohol or drug use disorder
* Taking a medication with a known side effect of memory impairment (e.g., benzodiazepines, opiates, or topiramate)
* Contraindication(s) for MRI