cyrilzakka/clinical-trials huggingface dataset:
Dynamic Profiles of Cytokine/Chemokine in Severe Acute Respiratory Syndrome

Severe acute respiratory syndrome (SARS) is an emerging infectious disease caused by a novel coronavirus (SARS-CoV). The major clinical features of SARS include fever, dyspnea, lymphopenia, and a rapid progression of pulmonary infiltrates on chest radiologic images. The SARS-related deaths have resulted mainly from pulmonary complications, including progressive respiratory failure due to alveolar damage and acute respiratory distress syndrome (ARDS). Pathological changes in SARS suggest that SARS sequelae such as infiltration of PMN in lung tissue, multiple organ dysfunction and ARDS have been associated with cytokines and chemokine dysregulation. Some patients still manifested lung injury at a time when the viral load was falling also supports the immune nature of the lung damage. We therefore undertook an analysis of dynamic production of cytokine/chemokines in SARS patients with an initial normal chest radiograph in order to improve understanding of disease pathogenesis and improve patient management.


Eligibility Criteria:
Inclusion Criteria:

* SARS group: Patients with SARS

Exclusion Criteria:

* Hospital acquired pneumonia
An Extension Study Assessing the Safety and Efficacy of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II

The primary objective of this extension study is to assess the long-term safety and efficacy of AVTX-803 in subjects with LAD II (SLC35C1-CDG).


Eligibility Criteria:
Inclusion Criteria:

* Subject must have completed protocol AVTX-803-LAD-301
* Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)

Exclusion Criteria:

* Subject has severe anemia defined as hemoglobin \<8.0 g/dL (\<4.9 mmol/L)
* Subject has impaired renal function as defined by an eGFR \<90 mL/min
* Subject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational product
* In the investigator's opinion, subject has a history of failure to respond to fucose at adequate dosing
Cell Content of Sputum Induced by Hypertonic Saline in Adolescents With Cystic Fibrosis

Cystic fibrosis requires regular monitoring of bacterial colonization of sputum. The collection is done during scheduled consultations or urgently during exacerbations during the respiratory physiotherapy session, which is increasingly often associated with nebulization of Hypertonic Salt Serum (SSH). This allows, compared to simple expectoration, to obtain a greater density and diversity of germs. However, no study has focused on researching the precise place of origin of the collected secretions. Our aim is therefore to compare, in this pilot study in 20 adolescents suffering from cystic fibrosis and regularly followed at the pediatric CRCM, the ratio between squamous cells (CM, ENT origin) and broncho-alveolar cells in sputum obtained spontaneously and induced with of the SSH (collaboration with Professor Roll). The secondary criteria are the CM/bronchial cell ratio, the CM/alveolar macrophage ratio, cell viability and microbiological diversity. The hypothesis of this research is as follows: the nebulization of SSH before expectoration makes it possible to obtain a greater quantity of secretions from the broncho-alveolar sphere than during simple expectoration. In the cohort of 165 patients followed at the pediatric CRCM of Marseille, only 25 patients correspond to the inclusion criteria: they are between 12 and 17 years old, master autogenous drainage as well as spontaneous expectoration in sufficient quantity to carry out the research. They must also have been in stable clinical condition for at least one month. Taking into account the non-inclusion criteria (refusal to participate, systemic antibiotic therapy, respiratory decompensation or upper airway infection, SpO2 less than 92% before nebulization, appearance of hemoptysis in the last three months), the number of subjects is fixed. To 20. Each patient participates in a single day of hospitalization scheduled at the pediatric CRCM: at 9 a.m. simple expectoration and at 1 p.m., expectoration caused by SSH. The subject is therefore his own witness. The study inclusion period is one year.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent between 12 and 17 years old with definite cystic fibrosis (two CFTR gene mutations identified and positive sweat test)
* Patient followed at the pediatric CRCM of Marseille
* Patient able to expectorate spontaneously and master autogenous drainage
* Patient in stable clinical condition for 1 month

Exclusion Criteria:

* Patient refusing the study
* Patient under systemic antibiotic therapy
* Patient with respiratory decompensation or upper airway infection
* Patient with oxygen saturation \< 92% before nebulization
* Patient with hemoptysis in the last 3 months
* Patients with decompensated heart failure
A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment

This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
* Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
* Women aged 18-37 years
* Women with body mass index (BMI) of 18.5-32.0 kg/m2

Exclusion Criteria:

* Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
* Women with history of recurrent miscarriage
* Women with contraindications to controlled ovarian stimulation with gonadotropins
* Women with three or more controlled ovarian stimulation cycles
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy

A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.

This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy subjects between the ages of 18 and 80 years, inclusive, with functioning ileostomies were planned to be enrolled. In the first treatment period (Period 1) all subjects received an IV infusion of 1 g ceftriaxone. Subjects had a 3 - 7 day washout period between Period 1 and Period 2. In the second treatment period (Period 2) all subjects received an IV infusion of 1 g ceftriaxone and 2 oral doses of either 75 or 150 mg of SYN-004, according to the randomization schedule, which were administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion.

Eligibility Criteria:
Inclusion Criteria:

1. The subject has a functioning ileostomy which has been in place for \> 3 months.
2. Male or female between the ages of 18 and 70 years, inclusive.
3. Other than a functioning ileostomy, the subject is free from clinically significant illnesses or disease.

Exclusion Criteria:

1. Subjects who have active hepatic, small intestine, or biliary tract disease.
2. Subjects who have active ulcerative colitis, Crohn's disease, other inflammatory bowel disease.
3. Subjects with known malignancy requiring treatment \< 6 months prior to study screening.
4. Subjects who have, in the opinion of the investigator, significant concurrent medical illness.
5. Subjects who are currently taking concomitant medications which may interfere with study evaluation.
6. Subjects who have received an investigational drug within 30 days or within a time period consistent with a washout period of 5 half-lives, whichever is longer, of the first dose of ceftriaxone.
7. Subjects with a known history of allergy to any cephalosporin, penicillin or any β-lactam antibiotic.
8. Subjects who have known active malabsorption syndromes(s) that, in the judgment of the investigator, could compromise the objectives of the study.
9. Subjects who have used any oral, intramuscular, or IV anti-microbial medication during the last 3 weeks prior to the screening visit.
Effects of Olive Oil on Nipple Cracking, Nipple Pain and Maternal Satisfactions

The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to Tri-Service General hospital postpartum unit. Eligible patients were randomized to olive oil group or breast milk group and evaluate the effect of olive oil for nipple pain, nipple trauma, and maternal satisfaction.

Previous studies have shown that olive oil, applied to the skin, has analgesic and anti-inflammatory properties. It is proposed in this study that olive oil may also help prevent cracked nipple and sore nipple in breastfeeding mothers. The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension of maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to TSGH postpartum unit. Eligible patients were randomized into two groups of 40 women. In Group 1 Olive oil will be applied on the nipple after breastfeeding, and in Group 2 drops of breast milk were applied to the nipple after feeding. Clinical evaluations were made during the first 3 days of treatment and the 7th and 10th day after delivery. Furthermore, we will check the 1month breastfeeding rate data, which collected by the hospital nurse for baby-friendly hospital policy.

Eligibility Criteria:
Inclusion Criteria:

* Normal spontaneous delivery.
* Pregnancy weeks between 37-42.
* Single birth.
* Initiated breastfeeding.

Exclusion Criteria:

* Presence of crack in the nipple.
* Medication applied to the nipple
* The maternal health condition that may interfere with breastfeeding.
* The infant with congenital abnormalities that would impair breastfeeding.
* The infant attained low birth weight or other criteria to intensive care unit.
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis

The purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment.

This is a randomized, double-blind, parallel-group , placebo-controlled, multicenter US-based study to evaluate the safety and efficacy of 3 dose levels of NG101 (Metopimazine mesylate) compared with placebo in participants with diabetic or idiopathic gastroparesis.

The study will enroll approximately 140 participants. Following the Screening Period, there is a 2-week Pretreatment Period during which participants will complete an electronic daily diary. Participants eligible for the clinical study will be randomly assigned (in a 1:1:1:1 ratio) to receive either NG101 5 mg, 10 mg, or 20 mg, or matching placebo during a 12-week Treatment Period. All participants will be asked to take one capsule 30 minutes before a meal 3 times a day and 30 minutes before bedtime for a total of 4 capsules daily (QID). The total duration of the study for each participant will be approximately 20 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with diabetic or idiopathic gastroparesis
* Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain)
* Documented evidence of no mechanical obstruction
* Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test

Exclusion Criteria:

* Uncontrolled diabetes (defined as HgbA1c \> 10%)
* Severe postural symptoms or evidence of unexplained recurrent dizziness
* Participant has received and tolerated domperidone and showed no notable symptomatic improvement in gastroparesis symptoms
* Participant has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.
* Participant engages in daily recreational use of marijuana
* Prolactin levels \> 2 x ULN
Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy

This study will evaluate the safety and tolerability (maximum tolerated dose (MTD) within the specified dosing range) of single intravenous (IV) infusion of C2N-8E12 in patients with progressive supranuclear palsy (PSP).

This study evaluates the safety, tolerability, pharmacokinetics, and maximum tolerated dose (within dosing range) of intravenous (IV) infusion of C2N-8E12 in 32 patients with progressive supranuclear palsy (PSP). Four sequential cohorts will receive increasing single doses of either C2N-8E12 or placebo. Out of every 4 patients enrolled 3 patients will receive drug and 1 will receive placebo. Study participants will be followed for a minimum of 2 months post-treatment to monitor for the safety, tolerability, pharmacokinetics, and immunogenicity of C2N-8E12.

Eligibility Criteria:
Key Inclusion Criteria:

* Meets NINDS-SPSP possible or probable criteria as modified for NNIPPS and AL-108-231 clinical trials
* Brain MRI at Screening is consistent with PSP;
* Stable medications for Parkinsonism for at least 2 months prior to Screening;
* Agree to use protocol specified methods of contraception.

Key Exclusion Criteria:

* Signs of a progressive neurological disorder that better meets the criteria for types of neurological disorders other than PSP;
* Currently on any other biologic or immunomodulatory therapy;
* Subjects that reside at a skilled nursing or dementia care facility;
* Diagnosis of any other significant unrelated neurological or psychiatric disorders that could account for cognitive deficits;
* Untreated major depression at baseline evaluation, based on clinical judgment and results in geriatric depression scale;
* Unable to tolerate MRI scan at Screening or any other contraindication to MRI;
* Any contraindication to or unable to tolerate lumbar puncture at Screening, including use of anti-coagulant medications.
Ketamine for the Treatment of Opioid Use Disorder and Depression

The purpose of the study is to examine whether an investigational medication called ketamine is able to improve treatment outcomes for concurrent opioid addiction and depression when used in conjunction with buprenorphine treatment. Study medications will be delivered twice per week for four weeks. If you are eligible and you decide to enroll in the study, your participation will last approximately 8 weeks, or 2 months.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 to 65 years old.
2. Able to provide informed consent.
3. Meet DSM-5 criteria for Major Depressive Disorder, without psychotic features.
4. Score at least 20 on the Montgomery-Asberg Depression Rating Scale.
5. Fulfill a minimum of 4 of 11 current opioid use disorder criteria by DSM-5.
6. Have used opioids illicitly at least once in the past month.
7. Subjects must be on standard of care pharmacotherapy for OUD (buprenorphine) for at least one month.
8. Subjects taking other psychotropic medications (e.g. anti-depressants or non benzodiazepine anxiolytics) must be maintained on a stable dose for at least four weeks before study initiation.
9. Subjects must be considered to have treatment-refractory MDD as evidenced by failure or only partial response to treatment with at least two standard of care pharmacotherapy antidepressants.
10. Must consent to random assignment to intranasal ketamine or placebo control.

Exclusion Criteria:

They are considered an immediate suicide risk (by Columbia Suicide Severity Rating Scale of 4 or greater, a history of a suicide attempt in the past year, or by clinician judgment) or felt to be likely to require hospitalization during the course of the study.

2. They have a self-reported history of illicit ketamine use, or baseline urine drug testing positive for ketamine.

3. They are in acute opioid withdrawal (as evidenced by a score of 5 or above on the Clinician Opioid Withdrawal Scale). These subjects will be referred for clinical detoxification and pharmacotherapy induction. Subjects may be re-assessed for study eligibility after one month of treatment with a standard of care OUD pharmacotherapy.

4. Subjects who meet DSM-5 criteria for current bipolar disorder. 5. Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders.

6. Women who are pregnant or nursing. 7. Subjects with current hypertension as defined by a systolic blood pressure (SBP) \>140 mmHg or a diastolic blood pressure (DBP) \>90 mmHg.

8. Subjects with a self-reported history of delirium for any cause. 9. A history of allergic or other adverse reaction to ketamine. 10. Clinically significant abnormal laboratory values, physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, brain aneurysms, cardiovascular disease, or end-stage renal disease).

11. Electrocardiogram (ECG) findings (obtained within thirty days prior to randomization) of tachycardia, prior myocardial infarction, myocardial ischemia, or aberrant conduction).
Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)

Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial stress, anxiety, high levels of physical activity, and/or weight loss. Data from our group indicates that one-third of women with HA (mean age: 27 yrs) have preclinical cardiovascular disease (CVD) measured noninvasively as vascular dysfunction and vascular inflammation. This study will use HA as a marker of fertility status for cardiovascular health and perform dense-phenotyping using remote patient monitoring (FitBit) and patient reported outcomes (questionnaires) to determine which HA phenotypes are related to preclinical CVD and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Secondary amenorrhea of 3 or more consecutive months duration
* Include the screening hormones (eg, estradiol (E2) \< 50 pg/ml, Follicle-Stimulating Hormone (FSH) \<10 mIU/ml, and Luteinizing Hormone (LH) \< 10mIU/ml and other HA-defining hormones); or clinical diagnosis of HA by medical providers.
* Pre-menopause status.
* Able to give informed consent.

Exclusion Criteria:

* A diagnosis for secondary amenorrhea including prolactinoma, Polycystic Ovary Syndrome (PCOS), premature ovarian insufficiency, pituitary surgery, infection or infarction
* Pregnancy
* Psychotropic/illicit drug use
* Mental/neurological/major psychological disorders (other than depression and anxiety).
* Parturition/lactating in the last 6-12 months.
Markers of Alzheimers Disease After Propofol or Isoflurane Anesthesia

Previous work in animal models suggests that inhalational anesthetic agents may accelerate Alzheimer's disease pathogenesis, but it is unclear to what extent this may happen in humans. Here, the investigators propose to measure Alzheimer's disease-related neural markers in the cerebrospinal fluid (CSF) of patients exposed to anesthesia while undergoing neurosurgical procedures that require lumbar drain placement. Patients will be randomized to either receive inhalation anesthesia with isoflurane or intravenous anesthesia with propofol.

CSF and blood samples will each be collected at the induction of anesthesia, and then again ten and twenty-four hours later. CSF samples will be assayed for amyloid beta, tau, and other Alzheimer's disease-associated markers; blood samples will be assayed for serum inflammatory markers and used for genotyping studies. These studies should clarify the effect of common anesthetic agents on Alzheimer's disease related neural markers.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and above
* seen in neurosurgical clinic, and scheduled for operative aneurysm repair or other neurosurgical procedure necessitating lumbar drain placement.
* ability to speak English.
* ability to understand consent forms, and to give informed consent.

Exclusion Criteria:

* age less than 18
* lumbar drain is not placed
* not eligible for one of the anesthetics (inhaled isoflurane or IV propofol)
* inmate of a correctional facility (i.e. prisoners).
* pregnancy. Pregnancy is ruled out as standard of care before cranial surgery, based on clinical history and/or HCG testing
Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic Zirconia compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has less post-insertion complications after at least 1-Year follow-up ?

Study the behavior of implant supported rehabilitations made from full-zirconium dioxide (monolithic with buccal veneer (MZ) or full contour monolithic (FCMZ) ) and zirconia veneered with feldspathic (PVZ) in full-mouth type of rehabilitations (maxilla and mandible).

In a private clinic we will record the behavior, regarding prosthodontic and biological complications in different groups (MZ vs FCMZ vs PVZ) after at least 1 year in function.

We will make calibration of the investigators for prosthodontic and biological assessement and accepting an inter-observer agreement (Kappa) of 0.9 for each parameter.

Recording will be made without the help of magnifying utilities such as magnifying glasses or optical microscopes.

Eligibility Criteria:
Inclusion Criteria:

* Maxilla and/or Mandible Implant full-mouth restoration
* Monolithic ceramic or zirconia-feldspathic restoration
* be at least 18 years of age;
* present no systemic or local absolute contraindications for endosseous implant placement;
* at least 1 Year Follow-up

Exclusion Criteria:

* the presence of any systemic disease or condition that could compromise postoperative healing or osseointegration.
* Not full mouth rehabilitation
Impact Evaluation of a Social Franchise Model for Improving Infant and Young Child Feeding and Child Nutrition in Vietnam

Alive \& Thrive is an initiative that aims to improve infant and young child feeding practices and reduce childhood stunting. In Vietnam, Alive \& Thrive's primary intervention is implemented through a social franchise linked with the government's health system. The impact evaluation is conducted using a cluster-randomized design in which 20 commune health centers (CHC) were assigned to the social franchise model, and 20 CHC were assigned to routine government services. Repeated cross-sectional baseline and endline surveys will be used to assess the public health impact of this intervention. The baseline was in 2010 and an endline survey in the same communities will be conducted in 2014. Mixed methods process evaluation will be conducted in 2011, 2012 and 2013 to study the pathways through which the program impact is achieved.

Link provided to journal manuscript describing design of evaluation provides additional detail: http://fnb.sagepub.com/content/34/3_suppl2/S195.full.pdf

Eligibility Criteria:
Inclusion Criteria:

* Children 0-60 months of age

Exclusion Criteria:

* None
Probiotics and Endotoxemia

The purpose of this study is to determine whether probiotic treatment of overweight volunteers consuming high fat diet is able to reduce plasma lipopolysaccharide concentration.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 27 kg/m2; above 18 years of age
* Used to eat high fat diet (more than 40% of total energy intake)

Exclusion Criteria:

* Treated cardiovascular risk factors, treated hypertension, treated dyslipidemia, treated diabetes; Known diabetes, hypertension, dyslipidemia
* Severe illnesses
* Artificial heart valve
* Immunosuppression
* Regular consumption of probiotics
* History of bariatric surgery
* Consumption or wish to consume Orlistat
* Participation in other research
* Pregnancy or wishing/trying to get pregnant
* Inability to follow protocol.