cyrilzakka/clinical-trials huggingface dataset:
SCOPE Analytic Treatment Interruption Protocol

The goal of this study is to understand the interaction between HIV and the host at the earliest stages when HIV medications are paused. Volunteers with HIV will interrupt antiretroviral therapy (ART) and then have intensive studies preformed two to three times per week. Most will resume therapy within three weeks, even if the virus does not rebound during this time.

In this study, people living with HIV will undergo intensive sampling prior to and following an interruption of their antiretroviral therapy (ART). Individuals will be asked to resume ART once the virus is detectable, or after approximately three weeks if the virus remains undetectable.

Individuals who were able to control their virus before ART ("controllers") will be able to participate in an extended treatment interruption and have less restrictive ART restart criteria.

The overall goal of the study is to characterize the interaction between the host and the virus at the earliest stages of virus replication and to identify predictors of rebound before virus becomes detectable.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Age \>= 18
* Documented HIV infection
* Antiretroviral therapy for at least 12 months
* Screening plasma HIV RNA levels below level of detection (\< 40-75 copies/mL), and all available determinations in past 12 months also below level of detection (blips allowed)
* Screening CD4+ T-cell count \>350 cells/uL
* If of childbearing potential, willing to use two methods of contraception
* Willing to receive counseling regarding HIV transmission risk mitigation

Exclusion Criteria:

* Pregnant or plans to become pregnant during the course of the study
* Active hepatitis B, defined as (1) positive sAg or (2) positive cAb with negative sAb and positive HBV DNA
* Active hepatitis C, defined as positive Hep C Ab with positive HCV RNA
* Use of a non-nucleoside reverse transcriptase inhibitor and unable to switch regimen
* Significant cardiovascular or cerebrovascular disease
* Recent or prior (within past 5 years) malignancy
* Severe kidney disease (CrCl \< 50 mL/min via Cockroft-Gault method)
* Severe hepatic impairment (Child-Pugh Class C) or unstable liver disease
* Concurrent treatment with immunomodulatory drugs
* Unable or unwilling to use barrier protection or pre-exposure prophylaxis (PrEP) to prevent HIV transmission with sexual partners not known to be HIV-infected
Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children

The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold symptoms.

Double-blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Participant within 48 hours of the onset of common cold symptoms: headache, sneezing, sore throat, nasal obstruction, cough, coryza and body pain;
* Signed Consent of the patient;
* Participant whose tutors have the capacity to understand and consent to the child's participation in the clinical study, manifested by signing TCLE

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Patients with vaccine reaction;
* Patients who have uncontrolled asthma however, participants in use of pulmonary corticosteroids (alone or in combination with other products) will be allowed if they are in stable dose and diagnosed with controlled asthma;
* Patients with gastroesophageal reflux, gastric or duodenal ulcer or other serious disease of the gastrointestinal tract;
* Patients with diabetes mellitus type I and II;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with flu symptoms evaluation.
DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer

The purpose of this study is to evaluate the clinical validity of the proprietary DermaSensor Elastic Scattering Spectroscopy (ESS) device and classifier algorithm to support assessment of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in the primary care setting.

A prospective, single-arm, blinded, multicenter study conducted at 22 investigational sites in the United States and Australia. Eighteen sites located in the US and four sites located in Australia.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women of any ethnic group aged 22 and older
2. Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy
3. Patient is willing and able to read, understand and sign the Informed Consent Form (ICF)

Exclusion Criteria:

1. Lesion \< 2.5mm in diameter or \> 15mm in diameter
2. Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale)
3. Lesion on area of crust, psoriasis, eczema or similar skin condition
4. Lesion has erosion and/or ulceration with no area \>2.5mm intact
5. Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions)
6. Lesion in which the device tip cannot be placed entirely within the border of the targeted area
7. Lesion located on acral skin (e.g. sole or palms)
8. Lesion located within 1 cm of the eye
9. Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention
10. Lesion located on mucosal surfaces (e.g. genitals, lips)
11. Lesion located on acute sunburn
12. Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy
13. Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent
Clinical Trial for Valuation of the Effectiveness of Lactoferrine in the Prevention of Sepsis in New Premature Born. Bimonitorization of the Antinflammatory Mechanisms, Antioxidants and the Intestinal Microbiote.

To evaluate the efficacy of enteral administration of bovine lactoferrin (bLf) in the reduction of probable late sepsis or microbiologically proven in preterm infants with birth weight ≤ 1500 gr and / or gestational age ≤ 32 weeks.

To date there are no published clinical data that jointly assess the impact of direct Lf supplementation on oxidative status, on biomarkers of systemic inflammation and on the microbiota of premature infants with or without sepsis. Clarification of these additional questions is essential for a better understanding of the benefits and implications of enteral administration of Lf in preterm infants. The enteral administration of lactoferrin reduces the incidence of late sepsis in preterm infants of very low birth weight (BMPN). Enteral supplementation with lactoferrin in NBWNS can have a beneficial effect on the systemic oxidative and inflammatory state, and may contribute to the creation of a healthy faecal microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Both groups will include male or female children born preterm with birth weight ≤ 1500 g and / or EG ≤ 32 weeks. All tutors of patients, must sign the informed consent.

Exclusion Criteria:

* In both groups those subjects who do not meet the age and weight established at birth, have\> 72 hours of life at the time of inclusion, who do not sign informed consent or who have the following morbidities will be discarded: 1) Early sepsis or vertical; 2) Gastrointestinal congenital anomalies; 3) Chromosomopathies; 4) Congenital anomalies and / or genetic diseases without survival expectations; 5) Severe perinatal hypoxia.
Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)

This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).


Eligibility Criteria:
Inclusion Criteria - Rollover:

* Completed 8 weeks of treatment in one of the following double-blind clinical trials: CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]
* No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole

Inclusion Criteria - De Novo:

* Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and demonstrates serious behavioral problems - diagnosis confirmed by Autism Diagnostic Interview-Revised (ADI-R) or the patient meets the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and has a history of behavioral problems that are currently being treated with psychotropic medication
* Mental age of at least 18 months
* Male or female 6 to 17 years of age, inclusive, at the time of enrollment

Exclusion Criteria:

* Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each
* Patients previously treated and not responding to aripiprazole treatment
* The patient is currently diagnosed with another disorder on the autism spectrum, including pervasive developmental disorder-not otherwise specified (PDD-NOS), Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
* Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression
* A seizure in the past year
* History of severe head trauma or stroke
* Non-pharmacologic therapy (e.g. psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study
Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)

This extension study will assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).

This extension study will enroll subjects who have completed 12 weeks of treatment in Study ALT-801-105. It is designed to allow for an additional 12 weeks of treatment in order to assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in this extension study, signed prior to the performance of any study procedures
* Receipt of 12 weeks of investigational product with completion of the procedures in Study ALT-801-105
* Women who are not pregnant or breastfeeding

Exclusion Criteria:

* Meets any of the exclusion criteria in Study ALT-801-105 at the time of study entry
* Development of any of the following conditions at any time during Study ALT-801-105:

  1. Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105
  2. History of pancreatitis or hypersensitivity reaction to GLP-1 analogues
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices

Intracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed. One particularly promising innovation is the WEB (Woven EndoBridge), which permits placement of an intra-saccular flow diverting mesh across the aneurysm neck, but which does not require anti-platelet agent therapy. Currently, which treatment option leads to the best outcome for patients with WNBA remains unknown. There is a need to offer treatment with the WEB within the context of a randomized care trial, to patients currently presenting with aneurysms thought to be suitable for the WEB.


Eligibility Criteria:
Inclusion Criteria:

* patient with an intracranial aneurysm in whom WEB is considered an appropriate therapeutic option by the participating clinician
* aneurysm of maximum diameter of 4-11 mm
* may include (but are not restricted to) saccular bifurcation aneurysms of the middle cerebral artery, basilar bifurcation, carotid terminus, or anterior communicating artery aneurysms
* Recurring, persistent aneurysm after previous treatment can be included so long as the treating physician judges the aneurysm morphology to be appropriate.
* Ruptured aneurysms with WFNS ≤ 3

Exclusion Criteria:

* Absolute contraindication to surgery, endovascular treatment or anesthesia
* Patients unable to give informed consent
* diameter of the aneurysm ≤ 4 mm but ≥ 11 mm
* Ruptured aneurysms with WFNS 4 or 5
VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept

The purpose of the study is to investigate how effective VA111913 is at preventing menstrual pain in women with primary dysmenorrhoea.

Dysmenorrhoea is suffered by between 50% and 90% of women of child bearing age. Up to 30% of these women are non-responsive to the currently prescribed therapies. As such it represents an area of unmet medical need. VA111913 inhibits vasopressin-induced contractions of human myometrial strips and human myometrial blood vessels in vitro. By this mechanism, it is anticipated that the pain of dysmenorrhoea, a condition in which myometrial tone and contractions are increased and blood flow to the uterus is decreased compared to normal, may be reduced.

Subjects will be dosed with VA111913 TS and placebo in a cross over design during two consecutive menstrual cycles. They will be dosed for up to a maximum of 6 days, beginning 2 days before the onset of menstruation. Subjects will then assess the menstrual pain, bleeding and amount of analgesia required to treat symptoms during each cycle

Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 35 years old
* Not pregnant
* History of primary dysmenorrhoea
* Regular menstrual cycles
* Signed informed consent

Exclusion Criteria:

* Known secondary dysmenorrhoea
* Concomitant use of regular prescription or non prescription medications or herbal remedies
* Any clinically significant medical history or active disease
* Participation in another clinical study in the last 3 months
* Contraindication to chosen rescue medications or allergy to their constituents
* Other protocol defined eligibility criteria may apply
Genetic Alteration After Systemic Treatment in Breast Cancer

The purpose of this study is to investigate effects of systemic treatments on genomic profiles in patients with breast cancer and to compare genomic profiling between premenopausal and postmenopausal women by systemic treatments in breast cancer.

Prospective single arm trial using three patients' cohorts. One-hundred patients for each cohort and a total of 300 patients (600 biopsy samples) will be entered to this trial.

The hypothesis is that genomic alterations measured by CancerSCAN and cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be different between pre- and post-menopausal women and would be predictive biomarkers for each cohort according to pre- and post-menopausal status. Three groups of patients will be recruited:

1. The patients who receive neoadjuvant systemic treatments:
2. The patients who have distant metastatic sites at first and recur from surgery:
3. The patients who are going to receive first-line chemotherapy

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 20 years
2. Patients with histologically confirmed breast cancer at three disease status

   * Patients who are going to receive neoadjuvant chemotherapy with feasible biopsy site.
   * Patients who recur from curative surgery and have distant metastasis with feasible biopsy site. ; Patients must have received adjuvant chemotherapy after curative surgery.
   * Patients who are going to first-line palliative chemotherapy with feasible biopsy site.
3. Patients with PS ECOG 0 - 2
4. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
5. Written informed consent form
6. Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to study as defined below:

   * Haemoglobin ≥9.0 g/L (transfusion allowed)
   * White blood cells (WBC) \> 3 x 109/L
   * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
   * AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN

Exclusion Criteria:

1. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.
2. Double primary cancer (except for any cancer in remission for \> 5 years, cervix cancer in situ, basal cell cancer in situ, any in situ cancers that are resected)
Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand

Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete surgical resection, also known as a R0 resection. At present, the ability to perform a complete resection with negative margins is limited by the surgeon's ability to palpate and visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and costs while maintaining or improving surgical and oncologic outcomes, the investigators must develop technologies that improve visualization of the primary tumor and occult metastases, real time, during surgery. Recent research has demonstrated that the use of fluorescent probes that recognize cancer specific antigens can be used for this purpose when visualized using a prototype near-infrared multispectral imaging system.

This investigation will determine if folate-FITC, a fluorescent probe that recognizes the folate receptor (present in \> 90% of ovarian cancers) can facilitate surgical resection and detect tumor nodules not visible to the naked eye.


Eligibility Criteria:
Inclusion Criteria:

Women who are:

* Diagnosed with or at high clinical suspicion of primary ovarian cancer by either radiologic imaging or physical examination or biopsy or serum tumor markers
* Scheduled to undergo surgical cytoreduction via laparotomy
* At least 18 years of age
* Capable and willing to provide informed consent

Exclusion Criteria:

Women with:

* Known sarcomatous histologies
* Recurrent ovarian cancer
* Planned surgical approach via laparoscopy or robotic surgery
* A history of anaphylactic reactions to Folate-FITC or insects
* Inability or unwillingness to provide informed consent
Clinical Study of a Novel Hemolysis Point of Care Test at an Emergency Department.

This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of care test is introduced in an emergency department.

In a blood sample process, the preanalytical phase is accountable for a vast majority of laboratory test errors. Among preanalytical errors, hemolysis is the most frequent error of sample rejection. Recollection of blood from the patient causes extra suffering, increased turn-around-time hence delayed treatment, and unnecessary extra costs for the health care system.

Here is a novel method for hemolysis point of care detection (H-POCT) evaluated. The single use test is attached to the blood sample in direct conjunction to the sampling process.

Patients will be selected by consecutive selection at the emergency department if blood tests ordered by the physician meet the inclusion criteria. Patients will be randomized into one of two groups. All health care professionals participating in this study has attended in a standard education program in operating H-POCT.

If Allocated into the control group, n: 750, nurses and enrolled nurses will perform blood sample according to routine.

If allocated into the intervention group, n: 750, nurses and enrolled nurses will perform blood sample according to routine and screen all Lithium Heparin vacuum tubes. (for one or all of the analyzes: Liver status, Electrolytes and Troponin T.)

If the hemolysis point of care test (H-poct) indicate a positive test result the Lithium Heparin vacuum tube and the attached H-poct will be discarded and a new sample will be collected and screened for hemolysis until the user receives a negative sample that is not hemolyzed.

This study takes place in a county hospital with 430 beds and the emergency department treats 59000 patients yearly.

Eligibility Criteria:
Inclusion Criteria:

Blood sample analysis ordered:

* Electrolyte
* Troponin T
* ALAT, ASAT, ALP.

Exclusion Criteria:

* Incompletely filled tubes
* Minors (\< 18 years)
* Patient not fit according to the health care professional assessment