cyrilzakka/clinical-trials huggingface dataset:
Embryo Culture Under Constant 5% vs Gradient 8%, 5%, 2% Oxygen Concentration

The purpose of this study is to investigate the development of human embryos in vitro under two different oxygen concentrations; a static 5% during all five days of culture or under an oxygen gradient, starting with 8% from day-0 to day-3, continuing with 5% on day-3 and following with 2% of oxygen from the end of day-3 to day-5.

Several studies have shown that embryonic morphological parameters improved when the oxygen concentration in embryo culture was reduced from 20% to 5%. Early mammalian embryos developed faster, had shorter cell cycles, a higher blastocyst formation rate and a better integrity of the inner cell mass (ICM) compared to embryos cultured at 20% oxygen concentration.

Recent studies have shown that the oxygen concentration in the female reproductive tract is not static. In the fallopian tubes of higher mammals it is at around 8%, while in the uterus, at the time of embryo implantation, the oxygen concentration is almost anoxic (2%).

Mimicking such physiological conditions that better reflect the in vivo environment in the human reproductive tract is the goal of assisted reproductive technology (ART).

The aim of this study is to assess whether changing the static 5% oxygen during five days of in vitro embryo culture to the gradient of oxygen, starting with 8% from day-0 to day-3, continuing with 5% on day-3 and following with 2% of oxygen from the end of day-3 to day-5, better reflects conditions found within the human reproductive tract and improves embryo developmental characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Age of women between 18 and 35 years.
* Body mass index (BMI) between 18 and 30 kg/m².
* Only patients with ICSI procedure (male factor of infertility, excluding azoospermia) and blastocyst culture.
* Patients from first and second ICSI cycle attempt.
* Gonadotropin hormone-releasing hormone (GnRH) antagonist cycles.

Exclusion Criteria:

* Presence of endometriosis.
* Previous clinical intervention on ovaries.
* Connected endocrine or metabolic diseases.
* Presence of polycystic ovary syndrome.
Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery

to investigate the effect of remazolam benzenesulfonate in patients with ocular fundus surgery, so as to guide clinical anesthesiologists to choose more appropriate anesthetic drugs in fundus surgery

to investigate the effect of remazolam benzenesulfonate in patients with ocular fundus surgery, so as to guide clinical anesthesiologists to choose more appropriate anesthetic drugs in fundus surgery。There are three groups.In Group H, ciprofol + Remifentanil was used for maintenance of anesthesia, in Group R, remifentanil + Remifentanil was used for maintenance of anesthesia, in Group RF, remifentanil + Remifentanil was used for maintenance of anesthesia, at the end of the operation, flumazenil was used to counteract the residual anesthetic effect.The quality of postoperative recovery was compared

Eligibility Criteria:
Inclusion Criteria:

1. ASA I-II, patients
2. aged 18-65 years old;
3. Fundus surgery to be performed under general anesthesia ;
4. The expected duration of surgery is about 30-120 min ;
5. BMI: 18-30 kg/m2 ;
6. Those who signed the informed consent form and volunteered to participate in this trial

Exclusion Criteria:

1. Patients with known or suspected genetic susceptibility to malignant hyperthermia;
2. Patients with history of asthma;
3. Patients with severe heart diseases (NYHA ≥ III, severe arrhythmia, etc.) and cerebral or pulmonary diseases, liver or kidney dysfunction; or with unstable vital signs;
4. Patients with history of long-term narcotic analgesics application, including sedative and antidepressant drugs;
5. Patients with history of psychotropic drug abuse within 3 months;
6. Patients with long-term alcohol abuse;
7. People with mental disorder and unable to communicate normally;
Natural History of Cherubism Observational Study

To observe the natural history of cherubism.

The investigators will take a history and examine patients with cherubism to determine the natural history of the disease. The investigators also may take skin or blood samples (IRB approved 7256) from patients to learn more about this disorder.

Eligibility Criteria:
Inclusion Criteria:

patients with cherubism

Exclusion Criteria:

patients without cherubism
Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks

The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
* Genotype 1b infection
* Treatment-naïve and non-cirrhotic

Exclusion Criteria:

* HCV genotype or subtype other than GT1b.
* Any current or past clinical evidence of cirrhosis.
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).

The study will enroll approximately 100 subjects in two (2) parts:

Part A is an open label study and will enroll approximately 40 evaluable subjects with aGVHD across 4 cohorts. The total number of patients will depend on the number of dose escalations necessary to enable a decision to be made on the recommended dose to take forward into Part B of the study. The planned dose escalation will start with cohort 1, where subjects will receive EQ001 administered intravenously every two weeks for a total of 5 doses.

Part B is a randomized, double-blind, placebo-controlled study and will enroll approximately 60 additional subjects, randomized in a 2:1 ratio to either active treatment EQ001 (40) or placebo (20). Subjects will receive either EQ001 or placebo administered intravenously every two weeks for a total of 5 doses.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject at least 18 years of age for Part A, and at least 12 years of age for Part B.
2. Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non myeloablative conditioning regimens.
3. Have a clinical diagnosis of acute GVHD requiring systemic immune suppressive therapy.
4. Deemed by the investigator to be likely to comply with the planned procedure as required by the protocol for the duration of the study

Exclusion Criteria:

1. Presence of morphologic relapsed primary malignancy, treatment for relapse after alloHSCT was performed, or requirement for rapid immunosuppressive treatment withdrawal for early malignancy relapse.
2. Evidence of graft failure based on cytopenia(s), and as determined by the investigator.
3. Evidence of post-transplant lymphoproliferative disease.
4. Any prior therapy for acute GVHD, except for alloHSCT prophylaxis regimens or systemically administered corticosteroids.
5. As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect: the subject's participation in this clinical study, the subject's safety, or the reliability of the study data.
Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens

The primary objective of the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.

STUDY DESIGN:

* This protocol is a single-center, single-cohort, bioresearch study enrolling up to 8 participants. The cohort is as follows:
* Cohort 1: Colorectal Cancer: (n=8)
* The study will enroll participants per the eligibility criteria.
* Participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact (see section 11.0 for details). The biospecimens collected from participants on this study are stool samples.
* Confirmation of eligibility and medical record review by a member of the study staff will be completed for participants of the disease cohort before they are considered fully enrolled.

Eligibility Criteria:
Cohort 1: Colorectal Cancer

Inclusion:

1. The participant is willing and able to provide written informed consent
2. The participant is willing and able to provide appropriate photo identification
3. Participants aged 18 to 85, Inclusive
4. Participants have been diagnosed with Active Colorectal Cancer (CRC)
5. Subjects currently taking irinotecan

Exclusion:

1. Participants who are pregnant or are nursing
2. Participants with a known history of HIV, hepatitis, or other infectious diseases
3. Participants who have taken an investigational product in the last 30 days
4. Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
5. Subjects who are currently in remission for CRC.

   * Preference (not required for enrollment into study): Exclude subjects currently taking antibiotics\*
RCT to Evaluate Social Skills in Children with Autism Using VR Technology (SoCaVR)

The goal of this randomized clinical trial is to compare and learn about Virtual Reality (VR) in children with autism/Autistic children.

The main question it aims to answer is:

• Does the Floreo VR clinical product show clinical improvement in autism symptoms?

Participants will engage the VR product for twice a week for twelve weeks.

They will be randomized to either the Floreo Clinical Product or a VR Control group experience.

Researchers will compare the two groups to see if there is an effect on learning specific skills and behaviors.

The purpose of this study is to find out if Floreo's VR clinical program can help with autism symptoms such as social communication skills in autistic children. Recent advances in VR technology offers a new way to improve these types of skills in children with autism in an immersive and controlled environment.

Questionnaires answered by adult caregivers will be used to assess the child's behaviors during the time of treatment.

Clinician observations will also be conducted as a part of this study.

Eligibility Criteria:
Inclusion Criteria:

* Five to eighteen years old (inclusive) at the time of consent
* Legal guardian is able and willing to properly sign and date informed consent indicating that they have been informed about the study and able to complete all visits \[If age appropriate, an assent will also be administered to the participant to inform them of the study and give them an opportunity to proceed or decline\]
* Verified diagnosis of ASD documented by a qualified clinician according to DSM-V criteria
* Receiving therapies at least two times per week in a clinic setting
* Participant is able to complete and pass the VR orientation screening

Exclusion Criteria:

* Significant medical condition(s) \[examples listed below\] or other circumstances which, in the opinion of the treating clinician, would preclude compliance with the protocol, adequate cooperation in the study, or may prevent the participant from safely participating in the study:
* Uncontrolled neurological conditions such as epilepsy, migraine
* Current disorders affecting balance, such as vertigo
* Primary sensory impairment such as blindness or deafness
* Eye movement impairment, such as strabismus
* Participants are enrolled in another clinical study
* Participants known to be pregnant
* Participation in this study is not in the best interest of the child, at the discretion of the treating clinician and the primary investigator.
Molecular Panel Evaluation for Diagnosis of Infections of the Central Nervosous System

Infections involving the central nervous system (CNS), such as meningitis/encephalitis (ME), are serious clinical conditions associated with high morbidity and mortality rates, as well as significant long-term consequences. ME can be caused by a wide variety of pathogenic agents. Clinical symptoms may vary and it has been shown that early identification of the pathogens causing ME allows for timely and appropriate treatment, thus reducing permanent neurological damage. The multiparameter panel "QIAstat-Dx®Meningitis/Encephalitis" can detect in one hour on a sample of 15 bacterial, viral and fungal pathogens. In the diagnostic routine, Real-time PCR takes an average of 3 hours and culture examination 2 days. In addition, compared to other comparable rapid molecular systems, the "QIAstat-Dx" platform has the ability to generate a cycle-related threshold value (Ct) for the targets detected. This value may have a correlation with the viral load and thus provide in a short time not only the result of positivity, but also an indication of the amount of virus present. Other commercially available multiparameter molecular tests provide only qualitative data.

The study is on biological samples of cerebrospinal fluid, positive for viruses or bacteria of interest, retrospective, monocentric, non-pharmacological.

For each sample included in the study (170 total samples), the molecular/culture test result, provided by the normal diagnostic process at the Microbiology Unit, is available for comparison with those obtained with the multiparameter panel QIAstat-Dx® Meningitis/Encephalitis (ME) and QIAstat-Dx 1.0 analyzer.

The aim of the study is:

1. To evaluate the analytical sensitivity of the test by identifying positive samples for bacteria (culture comparison) and positive samples for viruses (qPCR comparison).
2. Compare the value of Ct obtained with the number of viral copies per ml of cerebrospinal fluid obtained by qPCR.

Eligibility Criteria:
Inclusion Criteria:

* 170 samples of CSF positive for virus and/or bacteria;
* Samples stored at -80°C, less than 5 years;
* Samples with a volume of at least 800μL.

Exclusion Criteria:

* Samples of a different matrix than CSF;
* Samples stored at room temperature;
* Samples for which diagnostic test results are not available;
* Samples with a volume of less than 800μL;
* Samples already thawed and refrozen.
Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

Cesarean deliveries are the most common surgical procedure performed in the United States. A significant decrease in cesarean delivery associated maternal morbidity has been achieved with preoperative prophylactic single-dose cephalosporin, widely used before skin incision. Also, on laboring patients and/or with rupture of membranes, several studies suggest that adding azithromycin to standard cephalosporin prophylaxis is cost-effective and reduces overall rates of endometritis, wound infection, readmission, use of antibiotics and serious maternal events. Azithromycin has effective coverage against Ureaplasma, associated with increased rates of endometritis. Although two-drug regimen has been suggested for laboring and/or patients that undergo cesarean delivery, no studies have investigated the potential benefits of two-drug regimen in non-laboring patients.

Cesarean deliveries are the most common surgical procedure performed in the United States, and scheduled cesarean deliveries account for at least 40% of all cesarean deliveries every year. A significant decrease in cesarean delivery associated maternal morbidity has been achieved with preoperative prophylactic single-dose cephalosporin given within 60 minutes of skin incision. Also, on laboring patients and/or with rupture of membranes, several studies suggest that adding azithromycin to standard cephalosporin prophylaxis is not only cost-effective but reduces overall rates of endometritis and wound infection. Azithromycin provides effective coverage against Ureaplasma, commonly associated with increased rates of endometritis. Although two-drug regimen has been suggested for laboring and/or patients that undergo cesarean delivery, no studies have investigated the potential benefits of two-drug regimen in non-laboring patients. No increase in neonatal morbidity was noted with adjunctive azithromycin prophylaxis, including adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18 years or older
* Women undergoing primary or repeat cesarean delivery
* Singleton gestation
* Gestational age greater than 34 weeks
* Pregnant patients undergoing scheduled cesarean delivery
* Intact membranes
* Non-laboring
* Signed informed consent

Exclusion Criteria:

* Maternal age \< 18 years
* Multi-fetal gestation
* Known allergy to cephalosporin or azithromycin
* Patient unwilling or unable to provide consent
* Diagnosis of rupture of membranes
* Intraamniotic infection, or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization.
* Immunocompromising medical conditions: HIV positive with CD4 count below 200, chronic steroid use, current diagnosis of cancer and/or chemotherapy age use
* Emergent cesarean precluding consent or availability of study medication
* Need for hysterectomy at time of delivery
* Use of antibiotic in the 72 hours prior to admission, with exception to patient receiving antibiotics for GBS
* Inability to contact patient on postpartum period.
Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment

This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment. The investigators will compare: fluoxetine maintenance at maximum dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the association of fluoxetine with clomipramine.

Arm 1: SSRI (Fluoxetine 40mg\* once a day) + Clomipramine 75mg\* once a day.

Arm 2: SSRI (Fluoxetine 40mg\* once a day) + Quetiapine 200mg\* once a day.

Arm 3: SSRI (Fluoxetine 80mg\* once a day) + Placebo once a day.

\*or maximum tolerated dose

We hypothesize that quetiapine and clomipramine will be effective augmentation strategies for resistant OCD patients in comparison to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. OCD diagnosis
2. YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions)
3. Previously signed informed consent to participate in this clinical trial

Exclusion Criteria:

1. Patients with clinical or neurological diseases that may be worsen by the medications included in treatment protocol
2. Current substance dependence or abuse
3. Current psychotic symptoms
4. Current suicide risk
5. Current pregnancy or intention to get pregnant before the end of the treatment protocol
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Male and Female

The purpose of this trial is to investigate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.


Eligibility Criteria:
Inclusion criteria:

* Healthy male and female subjects
* age of 18 to 55 years
* body mass index (BMI) of 18.5 to 29.9 kg/m2
* additional inclusion criteria may apply

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
* Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders
* additional exclusion criteria may apply
Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients

This is a randomized comparative clinical trial carried out to compare between laser ablation and surgery in treating anal diseases in inflammatory bowel diseases patients and find out if one is superior to the other.

Inflammatory bowel diseases patients with anal problems were divided into 2 groups, one group had traditional surgery and the other had laser ablation for anal diseases and results were compared between the 2 groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of inflammatory bowel disease ( non specific colitis, crohn's disease, ulcerative colitis).
* Patients who accidently discovered to have inflammatory bowel disease.
* Age group between 18 to 60 years old

Exclusion Criteria:

* Informed consent refusal.
* Proved malignancy in inflammatory bowel disease patients
* Patients less than 18 years old or more than 60 years old
* Contraindications to general and spinal anesthesia
* other types of colitis as ischemic colitis, pseudo-membranous colitis, infective colitis