cyrilzakka/clinical-trials huggingface dataset:
Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

The purpose of this study is to determine if the combination of gemcitabine and vinorelbine is effective in treating patients with advanced soft tissue sarcoma.

Patients will receive both gemcitabine and vinorelbine once a week for two weeks and then one week with no chemotherapy (1 cycle equals 21 days). Gemcitabine and vinorelbine will be administered on day 1 and day 8 of each cycle.

Blood tests will be performed on each day chemotherapy is administered. A CT scan will be done after every 2 cycles (approximately every 6 weeks) to determine the effects of the chemotherapy on the sarcoma.

A physical exam will be performed at the start of chemotherapy and at least every three weeks thereafter.

Patients will remain on this study as long as the disease does not progress or there are no unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of unresectable or metastatic soft tissue sarcoma
* Measurable disease outside of a prior irradiated area
* ECOG performance status 0,1, or 2.
* 0 or 1 prior regimens for advanced disease.
* Adequate end organ function, defined as bilirubin \< 1.8; SGOT/SGPT \< 2.5 x upper limit of normal (ULN); creatinine \< 1.5 x ULN.
* Negative pregnancy test
* Life expectancy of greater than 3 months

Exclusion Criteria:

* Patient has received any investigational agents within 28 days of first day of study drug dosing
* Two or more prior regimens for advanced disease
* Prior gemcitabine or vinorelbine
* Another primary malignancy
* Grade III/IV cardia dysfunction
* Female patients who are pregnant or breast-feeding
* Severe and/or life-threatening medical disease
* Known diagnosis of HIV infection
* Prior chemotherapy within 4 weeks prior to study entry
* Major surgery within 2 weeks prior to study entry
* Known hypersensitivity to either gemcitabine or vinorelbine
Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes

Schizophrenia has long been known to be an illness with significant evidence for a genetic predisposition. The purpose of this study is to determine the genetic abnormalities that cause childhood and adult onset schizophrenia.

It is known from genetic linkage and gene expression studies that the alpha 7 nicotinic receptor gene is abnormally expressed in people with schizophrenia. The immediate objectives of this proposal support the long-term objectives of a comprehensive description of the pathophysiology of schizophrenia and new drug treatments by carefully defining the physiological genotype-phenotype relationship for a single candidate gene. Subjects and family members with a mental illness or who appear to have a mental illness will be asked to undergo an interview, perform some mental tests and have a blood, urine, and saliva sample taken one time.

Eligibility Criteria:
Inclusion Criteria:

* Individuals thought to have schizophrenia or schizoaffective disorder, be the parent of such an individual, or be in the matched control group of unrelated individuals not thought to have schizophrenia or schizoaffective disorder

Exclusion Criteria:

* Unable to give informed consent;
* Psychotic disorder judged to be secondary to substance abuse, psychotic disorder that appears to be secondary to a known medical or neurological disorder, or severe mental retardation
A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye

The purpose of this study is to evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in patients with dry eye

This is a Phase 3, multicenter, randomized, double-masked study designed to evaluate the efficacy and safety of SI-614 ophthalmic solution compared to placebo in patients with dry eye. Approximately 230 male and female patients at least 18 years of age with dry eye in both eyes will be randomized to receive treatment with SI-614 or placebo in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Have history of dry eye in both eyes for at least 6 months prior to Visit 1.
* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1.
* If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and will be using an adequate method of birth control throughout the study period.

Exclusion Criteria:

* Have any clinically significant slit lamp findings at Visit 1 or Visit 2, including active blepharitis, meibomian gland dysfunction, lid margin inflammation or ocular allergies that requires therapeutic treatment and/or, in the opinion of the investigator, may interfere with the study parameters.
* Be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active ocular inflammation (eg, follicular conjunctivitis) at Visit 1 or Visit 2.
* Have had any ocular surgical procedure within 12 months prior to Visit 1, or have any scheduled ocular surgical procedure during the study period.
* Be a female who is pregnant, nursing an infant, or planning a pregnancy.
* Have a known allergy and/or sensitivity to the study drug or its components.
* Have a condition or is in a situation that, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patients' participation in the study.
Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib

Recently it has been suggested that specific mutations in the EGFR gene in lung cancer patients is associated with response to a novel drug targeting the EGF system. Recent research also indicates that there is a possible association to the degree of aggressiveness of the disease.

The importance of these mutations is controversial, because the data are based on small studies with highly selected patients.

In this project the investigators want to study the types and frequencies of EGFR mutations in both untreated and treated patients in a systematic manner and relate this to survival.

The thorough registration of patient data in DK enables us to create a strong The investigators expect this knowledge to be of greatest importance for future rational use of drugs targeting the EGF receptors.

Aim:

1. To establish a method for identifying the mutations in the EGFR gene in small clinical samples from lung cancer patients.
2. In a retrospective study(n=500) relate survival to the frequency and types of mutations in the EGFR gene in a Danish population of patients with advanced, inoperable non small cell lung cancer (NSCLC) diagnosed prior to the introduction of treatment directed towards EGFR.
3. In a prospective study (n=300), to identify the mutations in the EGFR gene in patients treated with erlotinib, a tyrosine kinase inhibitor targeting the EGFR. Presence of mutations will be related to the expression of other parts of the EGF system, to mutations in the gene coding for K-RAS and to treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are starting treatment with erlotinib and who has who has signed the informed consent.

Exclusion Criteria:

* None
Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers

The primary objective of the study is to compare the safety and tolerability of subcutaneous (SC) and intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male or female Japanese and Caucasian volunteers ≥18 and ≤55 years of age at the screening visit.
* Japanese subjects must:

  1. Be first generation Japanese, defined as born in Japan and both biologic parents are ethnic Japanese
  2. Have maintained a Japanese lifestyle that has not significantly changed since leaving Japan, including having access to Japanese food and adhering to a Japanese diet.
* Caucasian subjects must be Caucasian of European or Latin American descent
* Modest elevations in LDL-C (≥100 mg/dL, but \<160 mg/dL)

Key Exclusion Criteria:

* Significant concomitant illness
* Known allergy or sensitivity to monoclonal antibodies (mAbs)
* Previous exposure to anti-ANGPTL3 antibody
* Body mass index (BMI) \>35 kg/m2 at the screening visit

Note: Other protocol-defined inclusion/exclusion criteria apply
Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule

Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)

Total anticipated: 300 subjects (150/group). 2-dose group - 10-valent pneumococcal vaccine + DTPa combined vaccine (2, 4, 11 months); Comparator group - 10-valent pneumococcal vaccine (2, 3, 4, 11 months) + DTPa combined vaccine (2, 4, 11 months). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion criteria:

* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* A male or female between, and including, 8 and 16 weeks (56-120 days) of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of 36 to 42 weeks.

Exclusion criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) and ending 30 days after the last dose, with exception of BCG vaccination which can be given after the 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule) blood sampling and a minimum of 30 days before the pre-booster dose blood sampling.
* Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae.
* History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious chronic illness.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Ocular Microvascular Changes in Patients With Sepsis

This study evaluates differences in the ocular microcirculation between septic patients and healthy subjects and the course of ocular microvasculature in survivors and non-survivors over a 24 hours period of time in septic patients

Conjunctival imaging, using IDF video microscope, and retinal imaging, using portable digital fundus camera, as well as systemic hemodynamic measurements, were performed in septic patients at three time points: at baseline, 6 hours and 24 hours. Baseline conjunctival and retinal microcirculatory parameters were compared with healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with sepsis or septic shock within the first 24 hours after ICU admission

Exclusion Criteria:

* psychiatric disorders, brain diseases, chronic alcoholism, autoimmune rheumatic diseases
* ophthalmological diseases, such as glaucoma, age-related macular degeneration, diabetic retinopathy and cataract
Effect of Januvia on Ghrelin and Other Gut Hormones in Patients With Diabetes

The purpose of this study is to see the effect of Januvia on Ghrelin levels in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes

Exclusion Criteria:

* Renal failure
* Pregnancy
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device

Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One device


Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years or older with at least one diagnosed breast fibroadenoma.
* Diagnosis of fibroadenoma must be based on:

  * clinical examination,
  * women ≤ 40 years of age: ultrasound image alone; women \> 40 years of age: ultrasound image and mammogram,
  * histological confirmation of fibroadenoma of the breast.
* Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm.
* Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment.
* Patient must be able to understand the nature and the extent of the study and the procédures required and be willing and able to complete the screening and study procedures.
* Patient must give written informed consent (personally signed and dated) before completing any study-related procedure.

Exclusion Criteria:

* Patient who is pregnant or breast-feeding.
* Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion.
* Patient with implant on the treated breast.
* Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU.
* Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
* Patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.
Comparison Between Intralesional Injection of Plasma Rich Platelets and Candida Antigen in Plane Warts

To compare the efficacy of intralesional injection of autologous plasma rich platelets and candida antigen in treatment of patients with plane warts .

Cutaneous warts are benign tumors caused by infection of keratinocytes by different serotypes of human papillomavirus(HPV). Its incidence increases during the school years to reach a peak in adolescence and early adulthood, then declines rapidly through the twenties and more gradually thereafter.

Plane warts are mainly caused by HPV serotypes 3, 10, 28, and 41, presenting mainly in children and young adults. They present as skin colored or may be hyperpigmented smooth-surfaced, slightly elevated or flat-topped papules. They are polygonal or round in shape and range in sizes from 1 to 5 mm. The main sites of predilection for the plane warts are the face, dorsal aspects of the hands and forearms, often in a linear array.

Platelet rich plasma (PRP) is an autologous blood-derived product enriched in platelets. Platelets, also called thrombocytes, are blood cells that cause blood clots and other necessary growth healing functions. PRP represents a new bio technology that is part of the growing interest in tissue engineering and cellular therapy today. While it is of autologous origin, it reduces the possibility of adverse effects and transfusion-transmitted infections, so it is well-tolerated therapy for the patients. PRP has been used in the treatment of many cutaneous diseases such as alopecia and acne vulgaris. Its utility has been extended to other cutaneous diseases as melasma, hyperpigmentation, and burns, wherever it elicits tissue repair and regeneration.

Intralesional immunotherapy depends on the ability of the immune system to recognize certain viral, bacterial, and fungal antigens, such as Candida or Trichophyton antigens that induce a delayed-type hypersensitivity reaction, not only to the antigen but also against the wart virus, which in turn increases the ability of the immune system to recognize and eradicate HPV. This stimulated immune response could then subsequently destroy all the injected and noninjected lesions on the body, rather than the locally treated lesion.

Intralesional antigen immunotherapy has recently received increased attention and is considered by many authors a promising modality for the treatment of different types of warts, including the recurrent and recalcitrant variants.

Eligibility Criteria:
Inclusion Criteria:

* Patients proved as having clinically evident plane warts.
* Patients with both sexes with no age limits.

Exclusion Criteria:

* Patient receiving immune suppressive drugs.
* Patients with major comorbidities or concomitant malignancies.
* Patients with any evidence of immunosuppression including HIV infection.
* Patients with any eczematous skin disorder
* Those with any history of hypersensitivity to Candida albicans antigen.
* Patients with chronic systemic medical diseases and bleeding disorders .
An Electronic Personal Health Record for Mental Health Consumers

Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by shifting the ownership and locus of health records from being scattered across multiple providers to an approach that is longitudinal and patient-centered. Given the complex health needs and the fragmentation of care for persons with serious mental illnesses, these individuals could derive particular benefit from a PHR. However, there are currently no established PHRs developed for use in this population.

In order to fill this gap, the investigators propose to develop, test, and disseminate a Personal Health Record for persons with serious mental illnesses and one or more comorbid medical condition. The Mental Health PHR (MH-PHR) builds on an established personal health record which was developed in partnership with medical consumers and is in wide use in a number of communities in the United States and abroad.


Eligibility Criteria:
Inclusion Criteria:

1. Currently in treatment at the CMHC.
2. Serious Mental Illness: based on or chart review;
3. One or more Chronic Medical Condition as ascertained via administrative records.
Effect of Andiroba on Control of Post-whitening Tooth Sensitivity

This randomized clinical trial will evaluate the effect of an experimental gel containing andiroba oil (Carapa guianensis) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. Volunteers in this study will be randomized into 3 different groups - PG (placebo gel), KF2G (potassium nitrate gel) and AG (andiroba gel). Groups KF2G and AG will receive treatment with potassium nitrate desensitizing gel and the experimental andiroba gel, respectively. This will be applied to the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active manner, for 10 minutes. Group GP will receive the application of a placebo gel (without active ingredient), under the same conditions described for the other groups. Subsequently, all groups will undergo in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity will be collected using a form consisting of the visual analogue scale (VAS). Color measurement will be performed with a spectrophotometer at two times: baseline (T0) and one week after the 3rd bleaching session (T1).

All groups will undergo in-office whitening treatment, carried out in 3 sessions with a 7-day interval, according to the steps described below:

Prophylaxis; Application of gingival barrier; Application of desensitizing agent or placebo, according to the established groups; Handling of the whitening material following the manufacturer's instructions: application of Whiteness HP 35% whitening gel for 15 minutes each, totaling 45 minutes; Final removal of the whitening gel and gingival barrier, followed by rinsing with water.

The application of the desensitizing agent or its placebo will follow this sequence:

Relative isolation with cotton rolls; Active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes; Rinsing with water.

Eligibility Criteria:
Inclusion Criteria:

* good oral hygiene
* absence of active caries lesions
* never having undergone previous whitening therapy
* not present dental hypersensitivity
* don\&#39;t be a smoker
* not be pregnant
* present at least 28 teeth in the oral cavity.

Exclusion Criteria:

* volunteers who were under orthodontic treatment,
* presence of periodontal disease
* dental cracks or fractures
* restorations and prostheses on anterior teeth
* extensive molar restorations
* gastroesophageal disorders
* severe internal dental darkening
* presence of dentinal exposure in anterior and / or posterior teeth.
Medulloblastoma Online Video-based Exercise Pilot Study

In this study, the investigators test whether it is possible to deliver an exercise intervention via video meetings to children and adolescents who have completed therapy for medulloblastoma. The exercise sessions will be individualized and offered three times weekly during 12 weeks.

Tumors of the central nervous system (CNS) represent 25-30% of all cases of pediatric cancer in Sweden. The survival for children with a brain tumor has improved over the last years. The 5-year overall survival rate is now 70%, resulting in a growing number or survivors every year. Malignant brain tumors typically have a poor prognosis, and curative treatment usually requires a combination of neurosurgery, chemotherapy and/or radiotherapy. For the survivors, the cure often comes at the cost of long-term side effects. Finding effective ways to mitigate the long-term side effects after childhood brain tumor is important, since they can severely impact the survivors´ daily life.

There is growing evidence that physical exercise is beneficial to cognition and improves cardiorespiratory fitness and motor function. It appears to be important that interventions start early, within 1-2 years after radiotherapy. For this to be feasible in international multicenter trials, the intervention and outcome assessments will need to be delivered remotely. Whether this is feasible in children treated for medulloblastoma is not known.

The investigators will perform a pilot study to provide pivotal information on whether exercise training can be remotely delivered in the home environment in children treated for medulloblastoma. This will take exercise training from an interesting research concept into a scalable intervention that can be offered regardless of geographic location of the patient. The study will further define the validity and feasibility of in-home outcome assessments of cardiorespiratory, muscular fitness and motor function in children treated for medulloblastoma. If shown feasible, this will work as a proof-of-concept and lead the way for including physical activity intervention in other childhood cancer treatment protocols as well. The results from this study will also enable the researchers to proceed in the planning of the first exercise intervention to be included upfront in an international childhood cancer treatment protocol, the upcoming Pan-European treatment protocol for standard-risk medulloblastoma in children (SIOP-MB6).

Eligibility Criteria:
Inclusion Criteria: Completed therapy for medulloblastoma, including craniospinal radiation therapy, within 36 months before study entry.

-

Exclusion Criteria: Inability to walk without support. Progressive disease.

-