cyrilzakka/clinical-trials huggingface dataset:
Impact of School-based Delivery of Long Lasting Insecticide Nets

Insecticide-treated nets (ITNs), and more recently long lasting insecticide nets (LLINs), have been shown to effectively protect those groups most biologically vulnerable to the burden of malaria across Africa. However, achieving universal coverage, especially in poor and remote areas, has proved a particular challenge and there remains a need to explore alternative delivery mechanisms. The recent introduction of universal primary education in Kenya has meant that even the poorest households are sending at least one child to school, providing a complementary, potentially equitable, mechanism through which to distribute LLINs. The delivery of LLINs through schools will be piloted by Population Services International in schools situated along the Tana River in North Eastern Kenya. This proposal seeks to evaluate the impact of this programme on both household use of school donated, free LLINs and the health of schoolchildren. The study hypothesis is that the free delivery of long lasting insecticide nets (LLINs) through schools will increase household LLIN coverage among younger siblings not enrolled in school and will reduce rates of malaria infection and anaemia among school children. The study will be an impact evaluation of a programme delivering LLINs through schools, which is to be implemented by Population Services International (PSI)-Kenya. The programme will be implemented in 50 schools and due to PSI-Kenya's roll out, the programme will be phased in over two years. will be phased in over two years. The 50 schools will be randomly divided into two groups, the first 25 schools will receive LLINs in 2009 and the second group will receive them in 2010. In each school, five households will be randomly selected and household surveys will be conducted to collect information on household net use and household demographic and socio-economic status. School health surveys will be completed at the end of the programme to assess programme impact on malaria infection and anaemia.


Eligibility Criteria:
Inclusion Criteria:

* Pupil enrolled at participating schools in standards 1-7;
* Provision of informed consent from parent or guardian; AND
* Provision of assent by student.

Exclusion Criteria:

* Non-provision of informed consent; OR
* Pupils unwilling to participate in the study.
The Effect of Under-nutrition on the Human Microbiota

The purpose of this study is to determine whether a difference exists in the gut, oral, vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy and obese pregnant women. In addition, the investigators are setting out to determine if a micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of under-nourished pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 12 weeks pregnant
* between the ages of 18 and 40 years

Exclusion Criteria:

* Less than 12 weeks pregnant
Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest

The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.

Principal aim : prove the efficiency of early therapeutic hypothermia induced during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.

Secondary aim: prove the efficiency of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. Determine the number of ROSC, patients survival, neurological status 48 hours after cardiac arrest (GCS) and when leaving the hospital, impact following initial cardiac rhythm and the cooling rate of early therapeutic induced hypothermia.

Eligibility Criteria:
Inclusion Criteria:

* pre hospital cardiac arrest

Exclusion Criteria:

* under 18 years old
* pregnancy or breastfeeding women
* patient under guardianship.
* not beneficing a social health care system.
* cardiac arrest of traumatic origin
* patients with an initial body temperature under 34° C
* cardiac arrests for which resuscitation maneuvers seem unjustified (DNR criteria)
Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis

Endodrill is a new instrument for biopsy sampling in the GI-channel. The purposes of this study are as follows:

* Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis based on collected biopsies of tumors in the upper GI tract.
* Based on the quality of the collected tissue samples we want to evaluate which instrument generates the most useful material for genetic studies of the tumor.

Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators´ first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps.

In this study the investigators want to compare the Endodrill instrument´s ability to obtain representative tissue samples from tumors in the distal esophagus and cardia with a conventional biopsy forceps. In addition the investigators want to compare the tissue samples in terms of weight, quality, artefacts and whether either instrument is more suited for collecting tissue for genetic analysis. Such analysis will be conducted with Next-Generation Sequensing (NGS) of the whole exome, Whole Exome Sequensing (WES). In the event of positive results from these analysis the investigators will also conduct RNA-sequencing of the tumor tissue in order to start pre-operative mapping of genetic abnormalities.

20 patients will be enrolled for this study. For each patient the investigators will collect 10 biopsies, 5 biopsies each with conventional biopsy and the Endodrill instrument respectively. The order will be randomized for each patient. For each specific biopsy the investigator will choose a particular site on the suspected tumor tissue without knowing which instrument that will be used for the biopsy. This procedure will be repeated for all 10 biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with adenocarcinoma of the distal esophagus/cardia or stomach capable of stating a formal consent to participate in the study.

Exclusion Criteria:

* Mental illness
* Extreme co-morbidity (ASA \>3)
Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone

To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication

Exclusion Criteria:

* Patients with severe hypocalcemia (adjusted serum calcium level of \<7.5 mg/dL)
Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding

100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D power Doppler ultrasound using the international endometrial tumor analysis group and office hysteroscopy with taking samples for histopathological analysis.

The aim was to compare the efficiency of the upper mentioned interventions in diagnosing the cause of postmenopausal bleeding.

Eligibility Criteria:
Inclusion Criteria:

* 100 patients complaining of postmenopausal bleeding. Postmenopausal bleeding was defined as vaginal bleeding that occurred after at least 12 months of amenorrhea.

Exclusion Criteria:

* Exclusion criteria included any history of hormone administration in the last 6 months, any medical condition that might cause abnormal uterine bleeding like coagulation disorders, hypertension, cardiac disease, thyroid disorders or hepatic condition.
Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer

Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.

Endometrial cancer is the most common form of gynecological cancer in France with 6560 new cases in 2010. Endometrial cancers occurs generally after menopause but are sometimes diagnosticated before 40 years. The 5 years Overall survival of endometrial cancer is 76% (95% for non locally advanced or non metastatic disease).

Some factors are involved in disease prognostic: age, geographical origin, physical status, tumor grade, tumor histology and probably biomarkers. Some studies demonstrated that advanced age is a negative prognostic factor due to higher relapse risk and higher specific mortality. Unfortunately, Incidence of endometrial cancer will probably increase in future due to aging of the occidental population.

Current treatment of endometrial cancer is based on post-operative radiation therapy: adjuvant brachytherapy or adjuvant external beam radiation therapy. However these techniques lead to serious toxicity (digestive toxicity, ileitis...) in elder patient. Consequently, pelvic radiation therapy is difficult to organize before 75 years and dangerous to perform after 80 years.

However a new technique called: Intensity-modulated radiation therapy (IMRT) can make the difference. IMRT is a new high precision radiotherapy technique probably well adapted for old people, with less toxicity than current radiotherapy.

Nevertheless, IMRT is not recognized as a standard radiation therapy procedure in France and Europe.

Thus, goal of TOMOGYN study is to compare the tolerance of old women (at least 70 years), with endometrial cancer, treated with external beam radiation therapy or IMRT.

Eligibility Criteria:
Inclusion Criteria:

* endometrial adenocarcinoma histologically proven
* post op pelvic radiotherapy
* age ≥ 70
* performance status ≤ 2
* MMSE ≥ 10
* life expectancy ≥ 3 months
* social security covered
* signed informed consent

Exclusion Criteria:

* type I stade IAGI and stade IAGIII without myometer infiltration, stade IIIc2 and IV adenocarcinoma
* uterine sarcoma
* surgery not in accordance with recommendations of Inca
* previous uncontrolled or less than 5 years prior to diagnosis cancer
* cons-indication for radiotherapy
* diarrhea ≥ 3 per day
* pelvic lymph nodes \> 1cm not resected during staging
* previous sigmoid diverticulitis, crohn disease, systemic disease, ulcerative haemorrhagic, collagenosis, infectious peritonitis
* IMRT other than tomotherapy
* photon energy \< 10MV
* patient under guardianship
Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed

To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.

This is an open-label, multi-center, long-term treatment study conducted only in Japanese sites. The subjects are patients who fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) (296.50=unspecified, 296.52=moderate severity, 296.53=severe without psychotic features, 296.54=severe with psychotic features), who have completed Study HGMP (NCT#00510146) and patients who did not participate in Study HGMP who have been recruited to participate in Study HGMS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be aged 18 to less than 75 years.
2. Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent.
3. All female patients must test negative for pregnancy.
4. Females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug.
5. Male patients who are not surgically sterilized must agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
6. Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR).
7. Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode, as defined in the DSM-IV-TR.
8. Patients must have a current Young Mania Rating Scale (YMRS) Total score =\<8.

Exclusion Criteria:

1. Is investigator site personnel directly affiliated with this study or their immediate families.
2. Is a Lilly employee.
3. Has previously completed or withdrawn from this study or any other study investigating olanzapine.
4. Is pregnant or nursing.
5. Has a serious, unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months.
Does a Clinical Support System for Parenteral Nutrition (PN) Facilitate the Judgement on Choosing the Most Effective Commercial Solution Per Patient (and Modify it, if Necessary)?

Standard formulas of PN have been developed and provided to patients. Only few randomized controlled studies compared standardized vs individualized PN. Individually tailored PN, only if standard PN solutions do not meet patient's nutritional needs. ASPEN society recommends the use computerized prescribing. Technology has enabled the incorporation of medical guidelines in CDSSs. New approach: Comparison of patient's calculated nutritional needs with commercial available solutions.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalize Patients unable to be fed via gastrointestinal tract.
* Hemodynamically stable patients.
* PN regimen should remain the same for the first 3 days.

Exclusion Criteria:

* Hemodynamically unstable.
* Anticipated need for parenteral nutrition less than 5 days.
An Extension of the CONCERT Protocol (DIM18)

An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of the 12 month DIM18 CONCERT study
* Mild-to-moderate Alzheimer's disease
* Probable AD, Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR)
* Mini-Mental State Exam (MMSE) score between 12 and 24, inclusive
* Stable on donepezil for at least 6 months

Exclusion Criteria:

* Other causes of dementia
* Major structural brain disease
* Unstable medical condition or significant hepatic or renal disease
A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
* Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever \[on one occasion \> 38°C\], hypotension, or local signs of inflammation).

Key Exclusion Criteria:

* Subject has any of the following forms of invasive candidiasis at Screening:

  * Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed),
  * Osteomyelitis,
  * Endocarditis or myocarditis,
  * Meningitis, endophthalmitis, or any central nervous system infection,
  * Chronic disseminated candidiasis,
  * Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract,
  * Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens,
  * Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection,
  * Patients who failed a previous antifungal therapy for the same infection,
  * Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis.
* Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 10-fold the upper limit of normal (ULN).
* Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score \> 9).
* Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.

  o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.
* Baseline QTcF ≥ 500 msec.
Physical Activity Level and Physical Activity Awareness

It is important to determine the attitudes and behaviors of individuals towards regular exercise participation in order to direct individuals to physical activity or to implement effective practices related to increasing their participation.

The aim of this study was to determine the awareness of physical activity in young adults, the relationship between physical activity awareness and physical activity level and to investigate the differences between sexes.


Eligibility Criteria:
Inclusion Criteria:

* healthy young females and males who want to participate to the study
* individuals who have smartphones

Exclusion Criteria:

* have orthopedic, physiologic, psychiatric, neurologic or systemic disorders
* have present medication
AHSCT Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma

Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma

This is a prospectiv , single arm, open-label, single-center study. This study is indicated for refractory and relapsed multiple myeloma. It aims to evaluate the safety and effectiveness of autologous hematopoietic stem cell transplantation combined with BCMA CAR-T to treat refractory and relapsed multiple myeloma. The main research is completely alleviated, overall reaction rate, and recurrence rate,etc. 50 patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* 1、BCMA positive accompanied by refractory/relapsed and resistance;
* 2、Patients with the tumor load is high and cannot be transplanted directly, before transplantation. Reduce the load through CAR-T treatment to prepare for transplantation;
* 3、Patient relapses after transplantation,donor lymphocyte infusion Invalid. The donor cells in the recipient body can be used or the donor cells can be collected directly.Prepare CAR-T to prevent recurrence and induce relapsing;
* 4、Repeated MRD (+) refractory drug resistant cases;
* 5、Male or female, 30-75 years old;
* 6、Anticipated survival time more than 12 weeks
* 7、Transplant subjects, regardless of their previous treatment, are eligible for inclusion after relapse；
* 8、Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
* 9、Those who voluntarily participate in the trial and sign the informed consent form

Exclusion Criteria:

* 1、Patients with the history of epilepsy or other CNS disease；
* 2、Patients with prolonged QT interval time or severe heart disease；
* 3、Pregnant or breastfeeding;
* 4、Active infection with no cure;
* 5、Patients with active hepatitis B or C infection;
* 6、Previously treated with any genetic therapy;
* 7、The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 8、Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
* 9、Those who suffer from other uncontrolled diseases are not suitable to join the study;
* 10、HIV infection;
* 11、Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Intensive Nutrition Counselling in Patients With Head and Neck Cancer

The purpose of this study is to assess the effect of a pre-planned patient-adjusted intensive nutritional counselling given by a dietitian several times during (chemo)radiotherapy vs. individualized nutritional counselling given by a dietitian once in the beginning of (chemo)radiotherapy and thereafter on-demand in patients with head and neck squamous cell cancer.

* A sample size of 102 patients was identified to achieve 30% reduction in prevalence of malnutrition at the end of treatment (50% to 20%), with a significance value of 5% (p \< 0.05), 90% power. The second calculation was for a sample size of 88 patients for 30% reduction in prevalence of malnutrition at the end of treatment (50% to 20%) with the significance value 5% (p\<0.05), 85% power and effect size 70%. Based on these numbers, our aim is to recruit 100 patients, with the assumption that 12% patients would be lost to follow up.
* Randomization will be performed by the minimization procedure with the Minim Program® (http://www-users.york.ac.uk/\~mb55/guide/randsery.htm). The allocation will be done according to the following criteria: 1) Stage I-II vs. Stage III-IV; 2) age \<65 vs. \>=65 year; 3) Body Mass Index \<20 vs. \>=20 kg/m2 and 4) tumour location (oral cavity-oropharynx-tonsils vs. hypopharynx-larynx vs. nasopharynx).
* Adverse events of chemoradiotherapy will be classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events-3.0 (CTCAE v3.0)
* Nutritional status will be assessed by patient-generated subjective global assessment, nutritional risk screening-2002, upper-arm anthropometry (MAC, triceps skinfold thickness, MAMA), Bio-impedance, hand grip strength and weight loss.
* Survival: overall survival, disease-specific survival and disease-free survival are calculated.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary locally advanced squamous cell carcinoma of the oral cavity, pharynx, nasopharynx or larynx

Exclusion Criteria:

* renal function impairment
* liver insufficiency
* heart failure
* pulmonal impairment
* Chronic obstructive pulmonary disease
* cognitive impairment
* previous cancer in any location
* terminal stage
Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

The primary objectives are a) to establish the maximum tolerated dose of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine.


Eligibility Criteria:
Inclusion Criteria:

* Morphologic diagnosis of AML from bone marrow aspirate and biopsy
* Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33+, based on local laboratory criteria
* Age 18 years or older for relapsed or refractory patients for Phase I of this study

Exclusion Criteria:

* Patients with de novo AML of the M3 subtype
* AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of \> 2 months duration
* AML secondary to exposure to chemotherapy or radiation