cyrilzakka/clinical-trials huggingface dataset:
Chromosome 5Q Gene Variants and Asthma-Related Traits

To identify gene variants in human chromosome 5Q31-33 that may be involved in the pathogenesis of asthma.

BACKGROUND:

Markers and genes in chromosomal region 5q31-33 have been shown to be linked or associated to asthma or components of the asthma phenotype, suggesting that this chromosomal region is important in the genetic susceptibility to asthma, yet it has been difficult to show that a specific gene in this region plays a major role in asthma development or progression. Some of this difficulty arises from the fact that many genes are likely to be involved in the pathogenesis of asthma, with no single gene having an effect that will emerge as a major contributor, as well as the fact that the strong influence of environmental factors will complicate the analyses. Having recognized these issues, the investigators will use components of the asthma-associated phenotype, including eosinophilia and a compound "atopy" phenotype, to identify relevant asthma-related genes in this region. The identification of the genes and their genetic variants that may be associated with asthma and its related phenotypes may provide important new information on the pathogenesis of asthma.

The study is in response to a Request for Applications on "Positional Candidate Approaches in Asthma Gene Discovery" released in October 1999.

DESIGN NARRATIVE:

Dr. Martinez and his group have found linkage between markers in chromosome 5q31 and both eosinophilia and a composite 'atopy' phenotype. The goal of the study is to identify the gene variants in 5q31-33 that are responsible for these two linkage signals. This will be done using the same population of families enrolled in the Tucson Children's Respiratory Study that have now been followed since the time of birth of the index child approximately 18 years ago. In the first specific aim, gene variants having a frequency of 2% or more in a group of 25 known genes in chromosome 5q will be identified. The 25 genes have been selected among those that have been mapped to the 28 cM interval that was tested for linkage in previous studies. The second specific aim is to perform linkage disequilibrium mapping using 100 known polymorphisms in the region of approximately 6.4 cM that shows the highest likelihood of containing the gene variants responsible for either or both of the eosinophilia and atopy linkage signals. Detailed local mapping using both published and newly discovered polymorphisms in and around the areas of positive signals will also be performed. Based on the previous experience of these investigators for the same chromosomal region, several association/linkage signals in chromosome 5q are expected to be found.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B-NHL After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy

This is a phase I, single center study to assess the efficacy and safety of ThisCART19A in adult with Non-Hodgkins Lymphoma in China.


Eligibility Criteria:
Inclusion Criteria:

* Cellular or histopathological diagnosis of B-cell non-Hodgkin's lymphoma (B-NHL) includes: diffuse Large B-cell lymphoma (DLBCL), follicular lymphoma to DLBCL (tFL), follicular lymphatic (FL), Mantle cell lymphoma (MCL), primary Mediastinal Large B-cell lymphoma (PMBCL), etc.
* Failing to autologous CAR-T therapy.
* At least one available lesion to be assessed.
* Good organ function during screening.
* Should be confirmed Cluster of differentiation(CD)19 positive by biopsy for the patient who received target CD19 therapy before.

Exclusion Criteria:

* Allergic to preconditioning measures.
* Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.
* Uncontrollable bacterial, fungal and viral infection during screening.
* Patients had pulmonary embolism within 3 months prior to enrollment.
* Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.
* Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \< 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment.
* Had big lesion(single lesion diameter ≥10 cm).
* Bone marrow involvement≥5%.
* Receive allogeneic hematopoietic stem cell transplantation less than 100 days.
* Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. Or systemic diseases that require long-term use of immunization Inhibitor.
* Vaccinated with influenza vaccine within 2 weeks prior to lymphodepleting chemotherapy (Severe Acute Respiratory Syndrome-Corona virus disease 19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) .
* Patients who are receiving Graft versus host disease Hepatitis(GvHD) treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion.
* Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.
Intraoperative Ketamine and Magnesium Therapy for Control of Postoperative Pain After a Liposuction and Lipoabdominoplasty

Lipoabdominoplasty and liposuction are one of the most common plastic surgeries. The management of postoperative pain is complex. Non Steroidal Anti Inflammatory Drugs (NSAIDs) are insufficient, while opioids are avoided by their adverse effects and regional techniques are hampered by a premature discharge. In this context, the investigators seek an intraoperative multimodal analgesic technique blocking NMDA receptors with ketamine plus magnesium to significantly decrease postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Female and male
* 18 years or older
* Liposuction and lipoabdominoplasty
* ASA 1 and 2
* BMI 21-28 Kg/m2
* Full secondary education

Exclusion Criteria:

* Patients with surgeries added to the main proceedings
* Scheduled to tuck in Flor de Lis or Body Lift
* History of use of analgesic drugs 48 hours before surgery
* Peripheral central neurological diseases
* Known allergy will be excluded to medication in use in this study (ketamine, magnesium, clindamycin and penicillin or other)
FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine

The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of pancreatic adenocarcinoma
* Distant metastatic disease
* Scan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
* At least one lesion measurable by RECIST v1.1 criteria
* Life expectancy\> 3 months
* No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
* No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
* Pain must be monitored before inclusion
* 18 years \< age \< 75
* Performance status: WHO \< 2
* ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
* ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
* Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), creatinine \< 120 μmol/L, or MDRD creatinine clearance \> 60 mL/min
* Women of childbearing age must have a negative pregnancy test (β HCG) before starting treatment
* Women of childbearing age as well as men (who have sexual intercourse with women of childbearing age) must agree to use effective contraception without interruption for the duration of treatment and 6 months after the administration of the last treatment dose
* Patient affiliated to the social security scheme
* Patient information and signature of informed consent

Exclusion Criteria:

* - Other types of pancreatic tumours, especially endocrine or acinar cell tumours
* Ampulloma
* Presence of meningeal or cerebral metastases, bone metastases
* Gilbert's syndrome
* Presence of neuropathy\> grade 1 according to NCIC-CTC 4.0
* Contraindications specific to the studied treatments
* History of chronic diarrhoea or inflammatory disease of the colon or rectum, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
* Other concomitant cancer or history of cancer during the 5 years, with the exception of a carcinoma in situ of the cervix or basal cell or squamous cell carcinoma, considered cured
* Significant history of heart or respiratory disease, including any history of interstitial pneumonia
* Patient already included in another clinical trial with an experimental molecule
* Women who are breast-feeding
* Persons deprived of liberty or under guardianship
* Unable to submit to medical monitoring during the trial due to geographical, social or psychological reasons
Effects of SH T00658ID on Libido

The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.


Eligibility Criteria:
Inclusion Criteria:

* OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon
* Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline

Exclusion Criteria:

* Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.

The study was a randomized, double blind, placebo controlled study consisting of 2 substudies. In substudy 1, participants received 1 of 3 doses of ABT-267 or placebo + pegIFN/RBV for 12 weeks. In substudy 2, participants received pegIFN/RBV for 36 weeks. Participants were followed for 48 weeks post ABT-267 treatment for evaluation of efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Treatment naïve participants
* Females must be either postmenopausal for at least 2 years or surgically sterile
* Males must be surgically sterile or practicing specific forms of birth control
* Chronic hepatitis C virus (HCV), genotype-1 infected participants
* Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis

Exclusion Criteria:

* Pregnant or breastfeeding female
* Use of any medications contraindicated for use with pegylated interferon(pegIFN) or ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer
* Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder
* Current or past clinical evidence of cirrhosis or bridging fibrosis
* Abnormal screening laboratory results
Neuromodulation Treatment of Vestibular Migraines

This is a non-randomized pilot study to test the efficacy of neuromodulation via caloric stimulation on vestibular migraines. All subject who meet the study criteria will be in an active treatment group. All subjects will report the frequency of the migraines and undergo periodic testing of symptoms.

This is a non-blinded, non-randomized pilot study of individuals with vestibular migraines. The goal is to test the efficacy of neuromodulation on both migraine and dizziness symptoms in patients with documented vestibular migraines. Treatment will consist of 9 months of active treatment followed by 3 months of observation. The active treatment requires two daily 20 minute sessions wearing a device over the ears that delivers a very small amount of warm air to the ears. All subjects will undergo a series of tests at baseline and at discrete intervals during the 1 year of observation.

Primary and Secondary endpoints are listed below:• Primary Efficacy Endpoints

1. Reduction in the frequency and severity of migraine headaches (self reported in pain diary)
2. Reduction in the frequency and intensity of perceived vestibular symptoms (Dizziness Handicap Inventory (DHI), Activity Balance confidence scale (ABC), Oscillopsia Test, Symptoms questionnaire), OVRT Goggle profile.

Secondary Efficacy Endpoints for the Pilot Study

1. Improvement in sleep quality and/or quantity as assessed by the Epworth Sleep Scale.
2. Improvement in quality of life as assessed by the HIT-6 survey.
3. Improvement in mood/anxiety as assessed with the T2 Mood Tracker app (National Center for Telehealth \& Technology).

Eligibility Criteria:
Inclusion Criteria:

1. Adults, between the ages of 18 and 75 who have been diagnosed with VM least 3 months prior to entering into the study.
2. The Investigator must have confidence in the patient's ability to reliably use the CVS Device and complete the requirements of the study.

Exclusion Criteria:

1. are pregnant
2. have a history of cardiovascular disease
3. work night shifts
4. have a history of unstable mood disorder or unstable anxiety disorder
5. use a hearing aid
6. have a cochlear implant
7. abuse alcohol or other drugs
8. are experiencing Medication Overuse Headaches (individuals with respect to whom the Investigator is concerned that analgesic abuse is involved based on the ICHD-II guidelines).
9. have had eye surgery within the previous three months or ear surgery within the previous six months
10. have active ear infections or a perforated tympanic membrane
11. have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition

The purpose of this study is to gain information that may be useful in helping to figure out better or newer ways to provide nutrition to babies born premature.

Babies born premature weigh significantly less at the time of hospital discharge when compared to babies born at the corresponding age. The researchers in this study believe that the lower body weight at discharge may be due to lower muscle mass. However, there is no such information available for that at this time. It is important to have this information as babies who weigh less than normal at hospital discharge may develop higher blood pressure and higher sugar levels when they are 10-15 years old.

By doing this study, researchers will be able to have information about the baby's muscle mass, which will help the researchers to provide better nutrition to babies who are born premature. Researchers will also be able to determine if there are any differences in the muscle/fat mass based on the type of feeding (breast milk alone, formula alone or a combination of breast milk and formula). This information may be beneficial in helping to promote the appropriate type of feeding for babies born premature.

Eligibility Criteria:
Inclusion Criteria:

* Newborns \<32 weeks gestational age, singleton or multiple gestation
* 34-36 weeks gestational age newborns
* Term healthy infants from uncomplicated pregnancy

Exclusion Criteria:

* Babies with life threatening illness unlikely to survive
* Congenital and chromosomal anomalies
High and Low Intensity Speech Intervention in Children with a Cleft Palate: Perceptions of Children, Their Caregivers and Speech-language Pathologists

A cleft (lip and) palate (CP±L) is the most common congenital abnormality of the face and skull with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. The World Health Organization (WHO) highlights the significant financial costs, including morbidity, health care costs, emotional distress and social exclusion for patients, their families and society. The purpose of this study is to compare high- and low-intensity speech intervention in children with CP±L based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with CP±L and their caregivers). Individual semi-structured interviews will be conducted with both intervention providers and recipients to explore perceptions and experiences, as well as acceptability of the two speech intervention intensities. Potential participants will be told that the interview will be recorded. The actual interviews will take place at a location and time that is most convenient for the participants. Each interview will be recorded using a Roland R-05 high-quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographics. In addition, data regarding the type of cleft, time and manner of closure of the cleft, any secondary surgery and otological/audiological data will be collected from the medical records of the children with CP±L. Based on this qualitative study, possible adjustments to the high-intensity therapy protocol can be made. In doing so, these modifications will be relevant to these key stakeholders. This will also facilitate the implementation and widespread use of high-intensity speech therapy in clinical speech therapy practice.


Eligibility Criteria:
Inclusion Criteria:

* Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
* Aged between 4 and 12 years,
* Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist

Exclusion Criteria:

* Children with syndromic clefts
* Oronasal fistula
* Velopharyngeal insufficiency
* Hearing disabilities based on pure tone audiometry (\>25 dB HL)
* Cognitive and/or related learning disabilities or neuromuscular disorders
Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia

This study evaluates the effect of a cognitive remediation program on neurocognitive, social cognitive and metacognitive functions designed for patients living with a schizophrenia spectrum disorder.

Evaluation of the specific therapeutic efficacy of the ecological cognitive remediation program for schizophrenia spectrum disorder \[ECo-Sz\] on neurocognitive deficits, social cognition deficits and metacognition deficits of patients with a schizophrenia spectrum disorder.

In this double-blind (patients, outcomes assessors) controlled randomized trial the investigators compare patients receiving Ecological Cognitive training program for schizophrenia spectrum disorder \[ECo-Sz\] to patients benefiting from recovery-oriented therapy \[ThOR\]. Patients are treated for two months and monitored for four months.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia Disorder diagnosis, according to Diagnostic and Statistical Manual of mental disorders - Fifth edition (DSM-V) - Patient stabilized in terms of positive and negative symptomatology (absence or presence of weak positive and negative symptoms)
* Positive and Negative stable symptoms (no or few positive and negative symptoms)
* Stable and effective minimum dose of medication (antipsychotic) for the last three months
* Cognitive complaint expressed by the patient
* Informed consent form read, initialed and signed
* Understanding of spoken and read French
* Patient registered on the social welfare system

Exclusion Criteria:

* Other diagnosis at the forefront than Schizophrenia of the DSM-V
* Medical history neurological disorder resulting in hospitalization
* Acute episode in the last three month
* Somatic disorders resulting in cognitive impairment
* Engagement in a research protocol either currently or over the last month
* Neuropsychological assessment evaluation during the last six month
* Patients under the protection of a conservator (simple or reinforced)
* Individuals in vulnerable circumstances
A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia

The project will evaluate 1) the postprandial metabolism and 2) continuous glucose levels in subjects diagnosed with Idiopathic Ketotic Hypoglycemia (IKH)) and healthy control subjects.

IKH is a common, but not fully understood, condition in children, and in some the condition may persist in adulthood. In the present study we seek to evaluate the postprandial metabolism in adult subjects diagnosed with IKH through a clinical study including:

1. two test days, where the subjects completes a) an oral glucose tolerance test (OGTT) and b) a miced meal test (MMT). Before, during and after ingestion of the OGTT/MMT, blood samples will be frequently drawn for the evaluation of plasma glucose, hormones, amino acids and more. During both tests, the subjects will recieve a continuous infusion of primed glucose tracer to further evaluate the glucose metabolism.
2. a 14-day period where the subjects will lead the usual lives, wearing a continuous glucose monitor (CGM). This will enable us to evaluate long-term differences in plasma glucose levels in IKH.

Eligibility Criteria:
Inclusion Criteria:

* IKH-participants:
* Verified diagnosis of IKH by health professional
* BMI of 18-30 kg/m2
* Normal liver- and kidney function
* informed consent

Healthy control participants

* Normal glucose tolerance
* BMI of 18-30 kg/m2
* Normal liver- and kidney function
* informed consent

Exclusion Criteria:

* A history of diabetes
* close family members with diabetes
* use of drugs affecting the glucose metabolism that cannot be paused
* anemia
* any condition that the study investigators deem unacceptable for participation
* pregnancy or breastfeeding.