cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol

The aim of this study is to assess the oocyte yield of infertile women with suspected or known poor ovarian reserve (POR) undergoing a GnRH antagonist protocol for IVF with Merional® starting either with a low (150 IU) or a high dose (450 IU) and adding 100mg of CC (Serophene®) in the early follicular phase of the stimulation (day 3 to 7). To date no RCT has been conducted to compare the reproductive outcome of patients with POR as defined by the ESHRE Bologna criteria after controlled ovarian hyperstimulation with HMG in an GnRH antagonist protocol using low doses versus high doses of HMG and adding CC versus placebo. We hypothesize that adding 100 mg of CC on day 3-7 to a HMG antagonist protocol will lead to an additional increment of endogenous GT thus increasing the oocytes yield after controlled ovarian stimulation due to higher endogenous gonadotropin secretion.


Eligibility Criteria:
Inclusion Criteria:

* Age: \>18 years \< 43 years
* BMI: ≥ 18 ≤ 32 kg/m2
* Poor responder as defined by ESHRE working group

Exclusion Criteria:

* Age \< 18 und \> 43 years
* Pregnancy
* Breast feeding
* Uterine conditions interfering with endometrial proliferation and embryo implantation (submucous fibroids or polyps)
* Women diagnosed with PCOS according to the Rotterdam criteria
* Hyperprolactinaemia - untreated
* Both ovaries not accessible transvaginally for oocyte pick up
* Ovarian cysts of unclear dignity
* Evidence of hydrosalpinx on ultrasound
* Clinically significant severe systemic disease that are incompatible with pregnancy
* Known or suspected hypersensitivity to the active substances (gonadotrophins, ganirelix, progesterone, clomiphencitrate)
* Untreated thyroid or adrenal disorders
* Bleeding disorders
* Cancer
* Severe renal or hepatic dysfunction
* Necessity to take medication that could influence ovarian stimulation
* History of OHSS in prior IVF cycle
Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

The purpose of this study is to examine if infants are more likely to suffer from respiratory complications during their first year of life due to being born premature.

The overall objective of this study is to determine if infant respiratory morbidities after preterm birth are highly variable due to differential impairment of airway, parenchymal and vascular development that can be characterized as distinct physiologic phenotypes. If the nature and severity of these specific impairments of lung function are strongly associated with increased respiratory morbidities during infancy and that proteomic biomarkers can enhance the physiologic characterization of phenotype and prediction of late respiratory outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Infants born to mothers who are between the gestational ages of 24+0 and 36+6 weeks.

Exclusion Criteria:

* Cardiopulmonary defects
* Chromosomal defects
* Structural abnormalities of the upper airway, chest wall, or lungs
* Neurological/Neuromuscular disorders
* Infant not considered viable
* Family unlikely to be available for long term follow up
* Mothers under the age of 18.
* Non English speaking
Percutaneous Tracheostomy - Systematic Comparison Among Three Methods: Prospective Study

Percutaneous tracheostomy is routinely performed in most intensive care units in the world.Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room.

In our institution as in a number of institutions in the country, it is acceptable to perform the operation by placing the tube on a high position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by palpation of the neck.

Using technological aids, such as direct sonography and bronchoscopy in real time may significantly reduce the rate of complications as a result of performing percutaneous tracheostomy.

So far, no systematic comparison has been made among the three methods.

Percutaneous tracheostomy is routinely performed in most intensive care units in the world in a number of indications, such as: airway obstruction, need for a long respiratory support, improvement in respiratory toilet, prophylaxis before head and neck procedures and cases of severe obstructive sleep apnea.

Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room.

In many places around the world it is customary in to perform the operation under the guidance of a bronchoscope to prevent damage to adjacent structures, high or low position of the tube, and damage to the posterior wall of the trachea and to approve the final position of the tube. However, the use of a bronchoscope depends on the availability of the equipment, knowledge of the operator, temporary occlusion of the trachea and hypercarbia, increased length of the procedure, and maintenance cost (disinfection, replacement, etc.).

Ultrasound that is performed before percutaneous procedure may be useful in preventing damage to para tracheal adjacent structures, and preventing high placement of the tube. The use of duplex sonography with real-time visualization of the needle path is done routinely in procedures such as central venous catheterization, and may improve the safety and accuracy of percutaneous tracheostomy without causing airway obstruction or hypercarbia. Feasibility of the procedure has been reviewed in an article by Rajajee et al .

In our institution as in a number of institutions in the country, it is acceptable to perform the operation by placing the tube on a high position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by palpation of the neck.

So far, no systematic comparison has been made among the three methods.

Eligibility Criteria:
Inclusion Criteria:

* All intubated patients with various injuries requiring percutaneous tracheostomy (in- house and out- house patients)
* Minimal age 18

Exclusion Criteria:

* No patient consent for participation.
* Anatomical problem which does not allow for percutaneous tracheostomy and requires open procedure in the operating room.
Multicenter Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer (CLASS-01)

* Laparoscopic distal subtotal gastrectomy with lymph node dissection as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asian countries, even though the long-term follow-up outcome based on multicenter randomized clinical trial (RCT) is still awaited.
* For the patient with locally advanced gastric cancer, several studies indicated that laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, the application of it is controversial mainly due to lack of solid evidence on the oncologic efficacy. Therefore, conventional open approach is still the current standard for advanced gastric cancer.
* Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 per cent of all gastric cancer cases in China. Before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified.
* Accordingly,the comparison of intraoperative and postoperative complications between laparoscopic and open distal subtotal gastrectomy for over 65 years old patients with gastric cancer based on a randomized controlled trial is needed.


Eligibility Criteria:
Inclusion Criteria:

* Age from over 18 to under 75 years
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
* Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* ASA (American Society of Anesthesiology) score class I, II, or III
* Written informed consent

Exclusion Criteria:

* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values
Clinical Experience With the Hindfoot Arthrodesis Nail for the Surgical Treatment of Ankle and Hindfoot Pathologies

The aim of this observational study is to collect and evaluate the current clinical experience gained from the Hindfoot Arthrodesis Nail (HAN) for ankle and hindfoot fusions.

The HAN (Synthes) is a newly designed, titanium nail for trans-calcaneal, retrograde hindfoot fusion. The lateral bend allows an entry site in the center of the lateral column of the calcaneus, thus minimizing the risk of iatrogenic injury of the plantar neurovascular bundle.

Eligibility Criteria:
Inclusion Criteria:

* HAN fusion procedure ≥ 12 months before entering the study.
* Written or oral informed consent.
Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)

This study aims to explore the impact of three different suturing techniques (Running, Interrupted \& Locked) that used to close the uterine incision at the cesarean section on the formation of a cesarean scar niche


Eligibility Criteria:
Inclusion Criteria:

1. Women with a singleton pregnancy scheduled for elective cesarean section
2. Gestational age at the time of cesarean section between 38 and 40 weeks.
3. Willingness to participate in the study and provide informed consent
4. Age between 18 and 35 years old.
5. BMI \<30

Exclusion Criteria:

1. Known uterine anomalies or previous uterine surgery (e.g, myomectomy, uterine septum resection)
2. Pre-existing medical conditions contraindicating cesarean delivery or affecting uterine healing (e.g., Anemia, Diabetes)
3. Current smokers.
4. Non-cephalic presentation of the fetus.
5. Low-lying anterior wall placenta and placenta previa.
6. Inability to provide informed consent (e.g., cognitive impairment, language barrier)
7. Any condition deemed by the attending physician to pose a risk to the participant or compromise the study's integrity, for example, Patients who will require excessive suturing for further hemostasis or those who require ligation of one or both uterine arteries
IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients

Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels.

Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.

The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.

Eligibility Criteria:
Inclusion Criteria:

1. M/F patients 18 years of age or older
2. Diagnosis of ESRD (GFR ≤ 15 mL/min)
3. CAPD or APD using only Dianealand/or Physioneal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
4. DM (Type 1 and 2) on glycemic-control medication, for 90 days
5. HbA1c \> 6.0% but ≤ 12.0%
6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL

Exclusion Criteria:

1. Cardiovascular event within the last 90 days
2. Ongoing clinically significant congestive heart failure (NYHA class III or IV)
3. Allergy to starch-based polymers
4. Glycogen storage disease
5. Maltose, or isomaltose intolerance
6. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
7. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \< 77) at Screening.
8. Serum urea \> 30 mmol/L
9. Exposure to Extraneal or Nutrineal within the last 60 days prior to Screening visit, Day 1.
10. Receiving rosiglitazone maleate
Does the Addition of Manual Therapy Techniques Increase Gastrocnemius/Soleus Length More Than Stretching Alone?

This study will examine the short term effects of adding manual therapy techniques to static stretching in Dorsiflexion (DF) Range of Motion (ROM). The investigators will be studying 2 forms of manual therapy, a rear-foot thrust joint mobilization (TJM), and Instrument assisted soft tissue mobilization (IASTM). By comparing 3 groups: TJM+static stretching versus IASTM + static stretching versus static stretching alone the investigators wish to see if there are any short term benefits in DF ROM by adding either of these interventions to static stretching.

The manual therapy treatment will occur over 2 sessions and DF ROM measurements will be taken 4 times over a 2 week period.

The population that the investigators wish to examine are subjects with healthy feet and ankles, but with limited DF ROM.

The primary objective of this study is to see if subjects with decreased dorsiflexion motion will experience greater increases in dorsiflexion motion with the addition of manual therapy of static stretching alone.

Our hypothesis is subjects who receive manual therapy therapy and static stretching will experience a significant increase in DF ROM as compared to subjects who receive static stretching alone. More specifically subjects who are treated with the IASTM will experience greater results than subjects who are treated with the rear-foot thrust mobilization.


Eligibility Criteria:
Inclusion Criteria:

healthy feet and ankles must have limited dorsiflexion ROM. Limited dorsiflexion will be judged by patient having \<12 degrees of DF PROM with knee extended, or \<50 degrees of weight bearing DF ROM with the knee flexed.

Exclusion Criteria:

* inability to fully weight bear through their lower extremities
* have \<0-90 degrees of ROM in their knees
* inability to follow directions
* presence of a Lower Extremity fracture
* pregnant or nursing
Developing a Mobile Method to Measure THC-induced Impairment

Marijuana use, for both recreational and therapeutic purposes, is becoming increasingly common as states remove restrictions on use. The increased use raises new concern about the safety of this drug, including its ability to impair basic cognitive and psychomotor tasks, and whether the users are aware of their impairment. We propose to design a simple performance test that users can use in the field, using a cell phone, to assess their level of impairment relative to their own drug-free state. In this preliminary study, we will compare participants' simple task performance after a known dose of delta-9-tetrahydrocannabinol (THC), or placebo, administered under double-blind conditions. In our app the participants will be asked to gauge their own perceived level of impairment (as determined by self-ratings and judgments of impairment) as well as their actual impairment (as gauged by the app), providing important feedback and training about their ability to detect impairment.


Eligibility Criteria:
Inclusion Criteria:

1. 18-35 years old, males and females (N=44; 36 completers; 18 men, 18 women)
2. BMI 19-26
3. High school education, fluent in English
4. Experienced non-daily marijuana users

   Exclusion Criteria:
5. Current drug/alcohol abuse or dependence
6. Past year drug/alcohol dependence
7. Diagnosis with drug treatment for psychosis/bipolar/schizophrenia
8. Past year major depression
9. Panic/anxiety attacks in past 2 months
10. Post Traumatic Stress Disorder
11. Attention Deficit Hyperactivity Disorder
12. Cardiovascular illness, high blood pressure, abnormal EKG
13. Current medications
14. Pregnant or planning to become pregnant
STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Chronic renal anemia;
* Continuous stable intravenous maintenance epoetin therapy during previous month;
* Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months;
* Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
* Significant acute or chronic bleeding.
Spectral CT in Radiotherapy for Cervical Cancer

The purpose of this study was to explore the potential application of spectral CT for radiotherapy in cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

1. All patients were confirmed cervical cancer by pathology
2. patients were treated with concurrent chemoradiotherapy
3. Spectral CT scans acquisition performed during the arterial phase and venous phase
4. All the patients underwent a 18F-FDG PET/CT before treatment

Exclusion Criteria:

1. CT without spectral scans
2. History of allergy to intravenous contrast
3. Pregnant or potentially pregnant female subjects
Incorporation of a Health Equity Approach to Hospital Violence Intervention Programs: The Integration of a Community and Hospital Based Initiatives to Reduce Gun Violence in a Large Metropolitan Area

The purpose of this study is to evaluate the effectiveness of Houston-Hospital Violence Intervention Programs (HVIP) in reducing the occurrence of repeat violent events among adults receiving care at Memorial Hermann Hospital in Houston, to determine the impact of the community-engaged Houston-HVIP program on violent re-injury and mental and behavioral health, assess the impact of the Houston-HVIP program on racial and ethnic disparities in those impacted by firearm violence injury and to identify the predictors of implementation success, including dosage, reach, fidelity, and acceptability from the perspective of gun violence victims, health care providers, and community violence intervention specialists


Eligibility Criteria:
Inclusion Criteria:

* presented for a gunshot injury stemming from community violence at Memorial Hermann Hospital
* English or Spanish-speaking
* provide informed voluntary consent to participate in the study

Exclusion Criteria:

* presenting for a firearm injury arising from a self-inflicted gunshot, accidental firearm injury, unintentional gun violence, or domestic violence
Potential Research Study Participant Registry

The purpose of the potential research study participant registry is to keep potential research subjects informed about any future research studies in which they may meet the criteria for enrollment. The purpose of this study is also to assist current and future clinical trials with recruitment of subjects.

Methods:

Subjects will self identify themselves via the UCDMC Dermatology website to complete a survey regarding their interest in learning about future dermatology clinical research projects. Subjects provide contact information and check of a list of potential topics of interest.

Procedures:

Potential participants will find a link on the UCDMC Dermatology website to our registry. The potential participant will read information about the registry. If they wish additional information, they can follow a link to the potential research registry consent form. At this stage, the potential participant may answer, "no" to the consent form and they will be redirected back to the Clinical trials website. If they answer, "yes" then they will be linked to the registry questionnaire. The potential subject would then decide if they want to participate in the registry and if so what information they want to provide. The Clinical Research Coordinators would contact potential study participants to see if they meet the eligibility criteria for any of our current studies.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age

Exclusion Criteria:

* Under 18 years of age
Safety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease

The purpose of this study is to assess the effect of PYM50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* At least 50 years of age
* Diagnosis of possible or probable Alzheimer's disease
* Mini mental state examination score at least 16
* Good understanding of both written and verbal English
* A recent head scan that is consistent with the diagnosis of Alzheimer's disease

Exclusion Criteria:

* Recent history or clinical evidence of significant neurological disease other than dementia due to Alzheimer's disease
* Known to have another condition that is associated with dementia
* Use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine)
* Hormone replacement therapy started or changed within the previous 6 months
* Received any investigational drugs within the previous 12 weeks