cyrilzakka/clinical-trials huggingface dataset:
Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles

The present randomized controlled study aims to investigate the effectiveness of a combined regimen of letrozole and gonadotropin with dose adjustments based on body mass index (BMI) compared to a conventional only gonadotropin regimen in intrauterine insemination (IUI) cycles for couples experiencing unexplained infertility. The study was conducted at a tertiary university hospital's Assisted Reproductive Technologies (ART) center from January 2023 to January 2024. Couples with unexplained infertility were enrolled based on comprehensive assessments, and randomization was performed based on national ID (odd or even). The Conventional Only Gonadotropin (COG) group received recombinant FSH based on body mass index (BMI), while the Combined Letrozole-Gonadotropin (CLG) group received letrozole followed by gonadotropin with dose adjustments based on BMI. Ovulation induction and IUI were performed according to standard protocols. Clinical outcomes, gonadotropin consumption, and pregnancy rates were compared between groups. Among 317 IUI cycles, 131 couples with unexplained infertility were randomized (CLG: 61, COG: 70). Demographic parameters were similar between groups. The CLG group had lower daily gonadotropin doses (67 ± 18 IU/D vs. 76 ± 11 IU/d, p=0.01) and total gonadotropin consumption (750 IU vs. 825 IU, p=0.01) with comparable ovulation and clinical pregnancy rates. The COG group exhibited higher multiple pregnancy rates, although not statistically significant (CLG vs. COG; 1/61 vs. 3/70, p=0.4). The study suggests that the combined letrozole and gonadotropin regimen with BMI-based dose adjustments in IUI cycles for unexplained infertility is associated with reduced gonadotropin consumption and potentially lower multiple pregnancy rates.


Eligibility Criteria:
Inclusion Criteria:

* Couples with unexplained infertility
* Aged between 18-35

Exclusion Criteria:

* Male factor infertility
* Diminished ovarian reserve
* Patient refusion to participate
Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients

This goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. In this study, participants will receive the recombinant zoster vaccine. They will be monitored for adverse events and tested for antibody and cellular immunity.

This is an open-label, non-blinded study to assess the safety and immunogenicity of the Recombinant Zoster Vaccine (RZV) in young adult recipients of solid organ transplants (heart, liver, kidney). After obtaining consent, the patient will have pre-vaccine baseline Varicella Zoster Virus (VZV) anti-gE antibody testing performed by the Weinberg lab and then will be given first dose of vaccine. Participants will be brought back 30-60 days post-vaccine for follow up testing and second dose of vaccine. Participants will then be brought in for follow-up testing at 1-2 months, 6 months, and 12-15 months after receiving 2nd dose of vaccine. Testing for both antibody and cellular immunity to VZV will be performed throughout the study. Telephone, electronic and in-person follow up will be conducted to assess for any clinical signs of VZV reactivation, any vaccine-related side effects or any signs of acute rejection.

Eligibility Criteria:
Inclusion Criteria:

* 19 years of age or older and willing to provide written informed consent for the study participation.
* Prior recipient of solid organ transplant more than one year prior to participation.
* Stable immunosuppressive medication regimen for last 6 months prior to participation
* Participant must have a working telephone number, email address or patient Electronic Health Record (EHR) portal access and be willing to be contacted for study follow-up by any of these means.
* For participants of childbearing potential, use of effective pregnancy prevention till 2 months post last dose.

Exclusion Criteria:

* Active treatment with corticosteroids or other immunosuppressive agents for acute or chronic rejection.
* More than 2 courses of treatment for acute rejection within last 2 years prior to study enrollment
* History of anaphylaxis or other allergic reaction after receiving prior vaccinations or vaccine components
* Receipt of any inactivated vaccine 8 days before/after dose #1, subunit vaccine 14 days before/after dose #1 and live, attenuated or mRNA vaccine 30 days before/after dose #1
* History of herpes zoster, primary varicella or VZV vaccination within past 1 year prior to study entry
* Active pregnancy as defined by positive pregnancy test at the time of screening and prior to each dose of vaccine
* Febrile illness with Temp ≥39°C and/or infection that require hospitalization or oral antibiotics/antivirals/antifungal/anti-parasite medication within 14 days prior to day 1.
* Any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein

Randomized, parallel, double-blind clinical trial, comparing a partially hydrolyzed serum proteins infant formula with a conventional formula with intact protein in healthy infants that suffer from colic

Demonstrate that an infant formula with partially hydrolized cow's milk protein of serum proteins is equivalent to an intact protein formula in healthy children in terms of safety of use and suitability, to prove that it can be a alternative with digestive health benefits in healthy children with infant colic.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed as nursing colic according to Roma IV criteria.
* Infants who have received breastfeeding at least 2 weeks.
* Infants who at the time of inclusion in the study whose parents/legal guardians voluntarily decide not to continue exclusive breastfeeding or only maintain it in residual form (less than 20% of the daily intake, one breast intake per day).
* Full-term infants (\>37 weeks of gestation).
* Infants with weight suitable for their gestational age (2500-4500g).
* Normal APGAR score: 7-10.
* Infants between 2 and 8 weeks of life.
* Infants whose parents/legal guardians have signed informed consent.
* Infants with good availability of clinical follow-up until the end of the study.

Exclusion Criteria:

* Infants fed from birth with exclusive infant formula.
* Infants with congenital diseases or malformations that may affect growth.
* Infants with major medical conditions that require chronic medication or close medical checks.
* Infants who have taken any type of antibiotics or probiotics prior to the study.
Association of Amino Acid Prevalence and Chronic Brain Injury

Years after a suffering a brain injury, individuals remain in a physically and cognitively impaired state. The investigators believe that the concentrations of amino acids in the blood are chronically altered and yield negative effects on the individuals health. Preliminary data has shown significantly lower concentrations of amino acids in serum samples from the TBI population, these diminished levels of amino acids may be due to changes in the microbiome. Understanding these changes will help guide rehabilitative services for this population. Individuals with a chronic brain injury will donate samples of blood, oral tissue, and fecal matter to be compared to that of non-injured individuals. Genetic information from the hosts will be striped and discarded; participant's genetic information will not be retained. To better understand changes in the microbiome, any history of antibiotics and probiotics will be assessed.

The purpose of this study is to evaluate the levels of Amino Acids in adult individuals with chronic (\> 2 years) traumatic brain injury (TBI) when compared to a non-brain injured cohort population.

Preliminary data from an assay of amino acids in individuals with chronic TBI compared to an assay of individuals without a TBI revealed significantly lower concentrations of amino acids within the TBI group.

The composition and structure of the oral and fecal microbiome will be determined by 16S rDNA sequencing. Taxonomic and community structure profiles will be treated as outcome variables and modeled together with the participant's plasma amino acid concentration, years post-injury, age, sex and other variables to determine correlations. These correlations may improve our understanding of the diminished amino acid metabolism within the chronic TBI population.

The endpoint will identify the microbiome structure and composition by 16S rRNA gene sequencing within the TBI and healthy participants and to assess the participant's amino acid concentrations and other participant demographics and phenotypic characteristics (years post-injury, age, sex). This comparison may improve our understanding of the diminished amino acid metabolism within the chronic TBI population.

Eligibility Criteria:
Inclusion Criteria:

* Willing to donate 10 ml of blood
* Willing to donate oral tissue sample
* Willing to donate fecal sample

Exclusion Criteria:

* (for brain injured group) have a chronic (greater than two years) traumatic brain injury.
* Unable to provide to give voluntary informed consent
The Effect of Emotional Support Given During Cesarean Section on Pain, Anxiety, and Surgical Fear

The study was conducted to determine the effect of emotional support given during cesarean section on pain, anxiety and surgical fear.

The experimental study sample consisted of 120 women (emotional support group: 60, control group: 60). Data were collected using the Personal Information Form, Visual Analog Scale, State Anxiety Inventory and Surgical Fear Scale. In the comparison between the groups in the study, it was found that there was a statistically significant difference between the mean Visual Analog Scale scores of the women in the experimental and control groups in the pre-test (p\<0.05), and no difference in the post-test (p˃0.05). In the post-test measured after emotional support, it was found that there was a statistically significant difference between the State Anxiety Inventory scores, short-term, long-term and total Surgical Fear Scale scores between the groups (p˂0.05). After emotional support, women's pain levels increased, anxiety and surgical fear levels decreased and their satisfaction with emotional support during birth increased. Women who did not receive emotional support had significantly increased pain, anxiety and surgical fear levels.

Eligibility Criteria:
Inclusion Criteria:

* Women who had a history of spinal anesthesia for the first time during a cesarean delivery,
* Who were going to have a planned cesarean before spontaneous contractions started,
* Who had no health problems with their babies,
* Who had no physical or mental problems themselves,
* Who had no communication difficulties,
* Women who volunteered to participate were included in the study.

Exclusion Criteria:

* Women who had a normal spontaneous delivery,
* Women who had a cesarean after labor/spontaneous contractions started,
* Women who had any health problems with their babies,
* Women who had a physical or mental illness themselves,
* Women who did not want to participate in the study were not included in the study.
Comparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection

Because the ampulla of Vater is strategically located at the confluence of the pancreatic and common bile ducts, endoscopic resection of papillary neoplasms may be technically different from endoscopic mucosal resection in other parts of the gastrointestinal tract. The best method of endoscopic ablation and the optimal period for surveillance have not been established.

While some endoscopists advocate the use of submucosal injection of either physiologic saline solution or dilute epinephrine, some do not. Whether physiologic saline solution or dilute epinephrine should be used is also not established. Submucosal injection of either dilute epinephrine or saline solution may be useful for avoiding inappropriate resection because failure to lift the tumor from the proper muscle layer of the duodenum may indicate deeper invasion18 and is the strongest predictor of malignancy.

In adenomas of the major duodenal papilla, however, some investigators do not recommend submucosal injection. Not only the surrounding mucosa at the region of the duodenal papilla but also the tumor is lifted by submucosal injection, so capturing the lesion with a snare becomes difficult.

Eligibility Criteria:
Inclusion Criteria:

* ampulla of Vater adenoma
* no uncontrolled coagulopathy

Exclusion Criteria:

* adenocarcinoma of ampulla of Vater
* uncontrolled coagulopathy
* refusal to this study
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata

The primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.

A quadrivalent human papilloma virus (HPV) vaccine called Gardasil had recently (at start of study) been developed and approved by the FDA for the prevention of cervical HPV infection and cervical cancer, which is associated with infection from this virus. It is unknown whether the same vaccine could also be of benefit in treating anogenital warts, which are caused by the same virus. This is an important and clinically relevant question which needs to be answered. Anal warts have a high prevalence and recurrence and usually require extended lengths of treatment and follow-up, especially in the HIV population. At times, treatment of anal warts requires multiple surgeries to excise them if the burden of disease is high. Therefore, this disease represents a significant expense to patients and the health care system.

Further, the HPV virus that causes anal warts has been associated with anal cancer and with its preliminary lesion known as anal intraepithelial neoplasia (AIN). This study touches on two important, relevant and costly healthcare issues: finding a better treatment for the most common sexually transmitted disease in our country, and helping to prevent anal cancer, which is often a fatal disease.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* HIV positive status;
* CD4 \> 200 and viral RNA \< 400 on anti-retroviral therapy (HAART) or CD4 \> 350 if not on HARRT;
* the presence of anal warts that require surgical excision/ablation.

Exclusion Criteria:

* CD4 \< 200 and/or viral RNA \> 400 on HAART or CD4 \< 350 and not on HAART ;
* low burden of anal warts that would not require surgical excision/ablation;
* previous vaccinations against HPV or allergic reactions to any vaccine component;
* patients who are currently pregnant;
* patients with a previous diagnosis of anal cancer;
* patients who are incarcerated;
* patients who have taken immunomodulators (i.e. interferon, interleukin, corticosteroids, etc.) within the last 90 days;
* patients who have had an opportunistic infection in the last 90 days or who have another intercurrent illness that precludes their safe enrollment in this study;
* patients who, in the judgment of the investigators, are unlikely to adhere to the protocol, either because of a substance abuse or psychiatric diagnosis, or other factors that would affect compliance;
* failure to strictly comply with the vaccination schedule.
Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance.

Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. It represents an attractive and promising alternative to ferrous sulphate oral administration as pregnant women receiving lactoferrin did not experience any adverse effects.

This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron deficiency in pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with single fetus.
* Second trimester (14-20weeks of gestation).
* Normal Hemoglobin level: more than10g\\dl.
* Serum ferritin less than 15 mcg / L

Exclusion Criteria:

* Other type than iron-deficiency anemia (thalassemia, hemolytic anemia ... etc.)
* Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases ... etc.)
* Having hypersensitivity to iron preparations.
* Treatment with any other iron preparation in the last month.
* History of peptic ulcer, oesophagitis or hiatal hernia.
* Medical disorders with pregnancy.
* Need for alternative parenteral route to blood transfusion when rapid increase is required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) .
* Bleeding in early pregnancy.
* Refusal to participate in the study.
* Family history of thalassemia-sickle cell anemia or malabsorption syndrome.
* Recent blood transfusion.
* Inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral route.
Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC with Y90 SIR-Spheres

The overall objective of this research study is to evaluate outcomes associated with flex-dosing in Y90 SIR-Sphere administration in a prospective cohort of unresectable HCC patients eligible for segmental/super selective treatment at Methodist Dallas Medical Center (MDMC).

The overall objective of this research study is to evaluate outcomes associated with flex-dosing in Y90 SIR-Sphere administration in a prospective cohort of unresectable HCC patients eligible for segmental/super selective treatment at Methodist Dallas Medical Center (MDMC).

This study will enable physicians to be more precise in administering the correct radio-embolic dose, which will improve safety and efficacy of treatment while maintaining optimal dosing for tumor side effects. This study could potentially identify tumors earlier in the course of disease progression, which may result in more efficacious treatment and quality of life for patients. Earlier diagnosis and treatment may result in decreased costs.

This is a prospective cohort registry study. The prospective study cases will include all eligible Y90 patients, who meet the inclusion criteria who are treated beginning in May 2020 to May 2022. Follow-up of patients included in study will continue as needed in order to evaluate survival outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* All patients diagnosed with unresectable HCC in two of fewer hepatic segments at MDMC who undergo at least one SIRT procedure with Y-90 resin microspheres (SIR-Spheres®, Sirtex Medical Limited, Sydney, Australia) will be included in data capture. HCC is considered unresectable if it is multifocal or bilobar, or if the patient has malignant portal vein thrombosis, portal hypertension, or decompensated liver disease (Child-Pugh B or C).
* Eligible cases for inclusion are those that would have undergone Y-90 resin SIRT and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; platelets \>60,000; creatinine \<2 mg/dL; bilirubin \<2 mg/dL; and international normalized ratio (INR) \<1.2.

Exclusion Criteria:

* Subjects that do not meet the inclusion criteria
* Patients are not eligible for SIRT if they had any extrahepatic disease; contraindication to hepatic artery catheterization such as vascular abnormalities, bleeding diathesis, allergy to contrast dye, concurrent malignancy, refractory ascites, previous external beam radiation, or evidence of any uncorrectable flow to the gastrointestinal tract; or greater than 30 Gy of radiation estimated to be delivered to the lung based on angiography or Tc-99 microaggregated albumin scan (shunt fraction of 20% or greater).
Omega 3 Fatty Acids in Patients With Chronic Renal Disease

To study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and vascular function and inflammatory parameters in patients with chronic renal disease

In a double blind trial in patients with chronic renal disease, the effects of a 3.7 g supplement of docosahexanoic and eicosapentanoic acids or a supplement of a similar dose of corn oil during 12 weeks, will be assessed on the following parameters:

1. Urine albumin excretion
2. Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin
3. Carotid intima media thickness and pulse wave velocity
4. Inflammation status assessed measuring serum levels of C reactive protein and interleukin 6
5. Metabolic control of diabetes
6. Serum lipid levels

Eligibility Criteria:
Inclusion Criteria:

* Urinary albumin excretion over 30 mg/g creatinin
* Chronic renal failure stage 2 to 4
* Absence of serious conditions such as cáncer, decompensated heart failure, chronic infections and severe arterial lesions

Exclusion Criteria:

* Blood glucose levels over 180 mg/dl or glycosilated hemoglobin over 8%
* Presence of cognitive impairment that does not allow to sigin a written informed consent
* Alcohol or illicit drug abuse