cyrilzakka/clinical-trials huggingface dataset:
Psycho-education Intervention for Postpartum OCD and it's Influence on Symptom Severity and Treatment Self Referral Rates

The rationale for conducting the experiment including quantitative measures and a description of the method of recruitment:

This study provides psycho-educational intervention aimed at raising awareness of post partum Obsessive-Compulsive disorder (OCD) , reducing the intensity of symptoms and increase of self referral to treatment. Various studies report that 1-11% of women after childbirth suffer from OCD. A part of this population suffered from the disorder prior to giving birth and for some this is a first outbreak. This is a psychological disorder characterized by obsessions and compulsions. The disorder can appear or worsen at any time , and is characterized by different content depending on the stage of life. Obsessional thoughts after birth often includes harming the baby which alarms the woman and the surrounding, and affects her ability to care for the baby and develop a beneficial relationship with him. Studies support a bio-psycho-social model of OCD .and that adjustment period and physical changes after childbirth can be create a psychological biological and environmental background, to the development or worsening of OCD in women who suffer from or are prone to the disorder.

The present study deals with psycho-educational information which will be given to women after birth who were identified as susceptible to develop OCD. The information will be delivered in the maternity ward through written and recorded data , and sent through the system Qualtrics 4 weeks after birth. Psycho-education is an important first step in Cognitive Behavioral therapy for OCD and may lead to anxiety reduction and commitment to treatment. The information sent in the study is similar to the information provided at the beginning of standard Cognitive Behavioral Therapy.Women will be recruited from the maternity ward at Lis Maternity Hospital. In order to identify women at risk for OCD, All women in the maternity ward will be asked to fill a short questionnaire. Women found at risk or as suffering from OCD will be invited to participate in the study.


Eligibility Criteria:
Inclusion Criteria:

* Women are 48 hours after birth, meet the criteria for OCS (obsessive compulsive symptoms) or have previous history of OCD.
* Capable of filling computerized questionnaires.
* Capable of giving informed consent.

Exclusion Criteria:

* Substance use
Truth or Dare; Artificial Blastocoel Collapse Using Laser Before Blastocyst's Vitrification Versus Non-laser Usage

: This prospective randomized observational study aimed to compare behavior of artificially collapsed blastocysts to blastocysts that were vitrified without artificial collapse.

One arm study of 60 patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age limit 20-37 At least 6 good quality blastocysts per case. expansion rate 3-4

Exclusion Criteria:

* bad quality blastocysts expansion rate less than 3
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

A 12 week double blind study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

During the initial 12-week treatment period (Part A), a total of 3 doses of ponsegromab or placebo will be administered 4 weeks apart subcutaneously. Each dose contains two injections. Part B is an optional open-label treatment period consisting of ponsegromab administered every 4 weeks subcutaneously for up to one year. Part B does not include placebo.

Assessments include:

* Body weight measurements
* Measure the impact of ponsegromab compared to placebo on physical activity.
* Measure the impact of ponsegromab compared to placebo on appetite, fatigue, nausea, vomiting and physical function questionnaires.
* Blood samples to evaluate safety and additional endpoints including the amount of study drug in the blood and the effects of the study drug on levels of GDF15
* Up to 3 additional blood samples (two samples during Part A and one sample during Part B, if relevant) in a subset of participants as part of a substudy for more comprehensive assessment of the amount of study drug in the blood and of the effects of the study drug on levels of GDF-15.

Eligibility Criteria:
Key Inclusion Criteria:

* Documented active diagnosis of non-small cell lung, pancreatic, colorectal cancer
* Cachexia defined by Fearon criteria of weight loss
* Serum GDF-15 concentrations
* Signed informed consent
* ECOG PS ≤3 with life expectancy of at least 4 months to be able to complete Part A.

Key Exclusion Criteria:

* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
* Current active reversible causes of decreased food intake.
* Cachexia caused by other reasons.
* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.
* inadequate liver function
* renal disease requiring dialysis
The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion

Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to selectively reduce saturated fat and calories which will have a medically beneficial effect on LDL cholesterol and obesity. The purpose of the research is to evaluate this effect of α- cyclodextrin. It is hypothesized that alpha cyclodextrin supplementation will increase fecal fat on a high saturated fat diet compared to the same diet supplemented with a digestible carbohydrate control

Alpha-cyclodextrin which functions as a soluble dietary fiber, has been shown to a form a stable emulsion with dietary fat in the ratio of 1:9, with a higher affinity for saturated fat compared to unsaturated fat. In humans, supplementation with α-cyclodextrin has been shown to lead to a significant weight loss regardless of whether energy intake was maintained or increased.The aim of this study is to evaluate the results of a 72 hour fecal fat test using stool markers on the last three days of each of three six-day feeding periods. Subjects will be served a weight maintaining diet containing 40% fat (of which 40% will be saturated), 30% protein and 30% carbohydrate for 18 days. Subjects will also consume 1 gram alpha cyclodextrin with 1 gram of starch, 2 grams of alpha cyclodextrin, or 2 grams of starch in capsule form before breakfast, lunch, and dinner every day in each of the three six-day feeding periods. At this dose, alpha-cyclodextrin is recognized as safe by the FDA. All stools will be collected over a 72 hour period at the end of each feeding period and analyzed for fecal fat excretion.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 20 and 30 kg/m2 inclusive
* Weight ≥ 65 kg for females, and ≥ 55 kg for males

Exclusion Criteria:

* Pregnant or nursing.
* Diabetes Mellitus
* Any medication to reduce lipids
* History of gastrointestinal surgery, except for cholecystectomy or appendectomy
* History of malabsorption
Combination Therapy With NC-6004 and Pembrolizumab in Head and Neck Cancer Subjects Who Have Failed Platinum Regimen

In Phase IIa, dose-escalation study to determine the optimum tolerated dose and a recommended Phase IIb (RPIIb) dose in combination with pembrolizumab in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck who have failed platinum or a platinum containing regimen.

In Phase IIb, randomized control study between NC-6004 in combination with pembrolizumab versus pembrolizumab alone in the same subject population as Part 1 at the RPIIb dose identified in PIIa.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent for the trial.
* Males or females aged ≥18 years at screening.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Have histologically- or cytologically-confirmed HNSCC.
* Have recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies.
* Having prior platinum failure.

Exclusion Criteria:

* Subjects with carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary origination, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, nonsquamous histologies.
* Have disease that is suitable for locoregional treatment administered with curative intent or refuses curative intent.
* Have no more than 15% body weight loss due to the underlying condition in the last 3 months from signing of informed consent in Part 1 of the study and from randomization in to Part 2.
* Are currently participating in or have participated in a study of an investigational agent or are using an investigational device within 4 weeks prior to the first dose of trial treatment.
* Were previously treated with 3 or more lines of systemic therapies administered for recurrent and/or metastatic disease.
Transesophageal Echocardiography (TEE): A Novel Technique for Spinal Cord Imaging

The aim of this prospective observational study is to assess whether transesophageal echocardiography (TEE) can be used to identify the structures within the vertebral foramen of the spinal column and to determine the range of spinal segments which can be visualized.

The aim of this prospective observational study is to assess whether transesophageal echocardiography (TEE) can be used to identify the structures within the vertebral foramen of the spinal column and to determine the range of spinal segments which can be visualized. Data will be collected from both pediatric and adult patients undergoing cardiothoracic and interventional cardiac surgeries under general anesthesia. Because use of TEE is a standard surgical procedure and because TEE will already be in place to visualize the heart, no additional processes will be required to collect data, minimizing patient risk. TEE will be monitored and controlled by a trained anesthesiologist or TEE technician and visualization of the spinal cord will be confirmed. Real-time TEE images will then be captured and later graded by a trained sonographer as high, medium or low quality. Starting at the level of the tracheal bifurcation, corresponding to thoracic vertebral level T5 (Mirajalili 2012), the TEE probe will be advanced cranially to determine the spinal levels visualized above T5 and caudally in order to determine the spinal levels below T5 that can be seen on TEE. At each level seen on TEE, pictures will be taken for confirmation.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for cardiothoracic or interventional cardiac surgeries under general anesthesia

Exclusion Criteria:

* We will exclude any patients with known esophageal abnormalities, lesions or disease that would disqualify the patient for the use of TEE as standard procedure.
* We will also exclude any patients that come to the catheter laboratory exclusively for TEE exam as our study will only occur in patients already scheduled to undergo TEE use in surgery or diagnostic procedure.
Effect of Smart Phone Health Education on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition

The aim of this study is to investigate the effect of mobile health nutrition education intervention in the changing of dietary habits and body composition of overweight and obese 8-12 years old children in Sharjah, United Arab Emirates and to compare its effectiveness to paper educational intervention among the same age group.

The main questions it aims to answer are:

1. Are there any significant changes in dietary habits, physical activity and body composition among overweight and obese school-age children after three months of mobile health intervention?
2. Is there any significant difference between the effect of smart phone delivered and paper delivered interventions (changes in dietary habits, physical activity and body composition) among overweight and obese school-age children after three months of interventions?
3. Are there any significant changes in the obesity inflammatory panel among overweight and obese school-age children after three months of mobile health intervention?
4. Is there any significant difference in the sustainability of the outcomes between mobile health and paper delivered interventions among overweight and obese school-age children two months after the end of the intervention?
5. Are there any significant changes in nutrition related knowledge among parents of overweight and obese school-age children after three months of intervention?

Participants (children with their parents) will be randomly divided into intervention group and control group. Parents of children from the intervention group will receive two text messages/graphics per week about healthy eating and physical activity (PA) on their mobile phones during the intervention period (3 months). While parents in the control group will receive a one-time printed handout containing the same messages at the beginning of the intervention period.

Assessment of children's anthropometry, dietary intake and physical activity will be evaluated pre and post intervention and one more time after a two months period of maintenance after the end of the intervention. Parents' nutrition knowledge will be evaluated pre and post intervention only. Also, children salivary obesity markers will be measured at baseline and at the end of the intervention period to explore the effects of the intervention on inflammatory markers associated with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese children (over 2 SD based on the WHO Growth Reference (2007)).
* Between 8 - 12 years old.
* Attending school in Sharjah, UAE.

Exclusion Criteria:

* Children on a specific diet.
* Children who have any chronic diseases.

Parents qualify if their children meet the inclusion criteria, they can read and speak in Arabic, they plan to stay in Sharjah for six months from the beginning of the intervention, and they own and use a smart phone.
Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

Periprocedural bleeding events are frequent during transcatheter aortic valve implantation (TAVI), mainly driven by vascular complications and are associated to a worse prognosis. Therefore, red blood cell (RBC) transfusion is often required, although it is associated with worsened outcomes.

There is no consensus on the optimal transfusion strategy after bleeding. The Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) will be a multicenter retrospective registry enrolling consecutive patients who underwent TAVI; the primary aim of the study will be to test whether RBC transfusion is a marker or an independent predictor of adverse events.

Periprocedural bleeding events are frequent during transcatheter aortic valve implantation (TAVI), mainly driven by vascular complications and are associated to a worse prognosis. Therefore, red blood cell (RBC) transfusion is often required, although it is associated with worsened outcomes.

There is no consensus on the optimal transfusion strategy after bleeding: among patients undergoing cardiac surgery, the Transfusion Requirements in Cardiac Surgery (TRICS) III trial documented that a restrictive RBC transfusion strategy (if hemoglobin level was \<7.5 g/dl) was noninferior to a liberal approach (if hemoglobin level was \<9.5 g/dl) with respect to the composite occurrence of death, myocardial infarction (MI), stroke, or new-onset renal failure with dialysis.

The Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) will be a multicenter retrospective registry enrolling consecutive patients who underwent TAVI; the primary aim of the study will be to test whether RBC transfusion is a marker or an independent predictor of adverse events. Patients will be stratified according to their lowest hemoglobin value (\>9.5 g/dl, 7.5-9.5 g/dl and \<7.5 g/dl) and to whether they received or not periprocedural RBC transfusion.

The primary endpoint will be the 30-day occurrence of major adverse cardiovascular events (MACE), as death, myocardial infarction (MI), stroke, or acute kidney injury (AKI, as absolute increase in serum creatinine ≥0.3 mg/dL \[≥26.4 μmol/L\] or ≥50% increase ≤72 hours).

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion Criteria:

* age\<18 years
Norepinephrine Weaning in Septic Patients

The weaning rate of vasopressors drugs is usually chosen empirically by the clinician in critically patients. The investigators applied fuzzy logic principles to modify intravenous norepinephrine infusion rates during norepinephrine infusion in septic patients in order to reduce the duration of shock. The investigators goal was to reduce the duration of poorly controlled hemodynamic status.


Eligibility Criteria:
Inclusion Criteria:

* Septic shock

Exclusion Criteria:

* Less than 18 years
* Pregnancy
* Weight above 135 kg
* Requirement for continuous epinephrine infusion
* Severe head injury, stroke, a comatose state following cardiac arrest
Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women with hemoglobin ≥ 9.0 g/dl and ≤ 12.0 g/dl
* Willing not to donate blood during the study
* Informed consent signed

Exclusion Criteria:

* History of porphyria, hemochromatosis, or viral hepatitis
* Anemia other than iron deficiency
* BMI ≤ 18 kg/m2 or ≥ 30 kg/m2
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease
* Subjects who are taking medicines or functional food that may affect hemoglobin level
A Pilot Clinical Trial to Determine the Feasibility of Administering an Electronic Tool to Assess Postoperative pAin, Nausea, and Vomiting in English or Spanish-Speaking Pediatric Patients With Neoplastic Conditions.

The feasibility of using an electronic tool to measure pain, nausea, and vomiting after surgery in English or Spanish-speaking pediatric cancer patients.

Primary Objective:

To determine the feasibility of administering an AR-based electronic tool to assess postoperative pain, nausea, and vomiting in English or Spanish-speaking pediatric patients with neoplastic conditions.

Secondary Objectives:

1. To evaluate the willingness to use the AR app,
2. To evaluate the time spent using the AR app (recorded in the study device),
3. To calculate the difference (delta) between pain and nausea intensity recorded from the app and those gathered by nursing personnel,
4. To evaluate app recorded responses to pain intensity,
5. To evaluate app recorded responses to nausea intensity,
6. To assess the frequency of vomiting,
7. To measure the length of stay in PACU (calculated from the EMR),
8. To determine the rate (number) of assessments completed,
9. To calculate PACU opioid use,
10. To calculate opioid use during hospitalization,
11. To assess the quality of life using the PedsQL Cancer Module survey responses (administered by the study team),
12. To evaluate patient/caregiver satisfaction following the PACU stay
13. To assess nursing experience with AR tool following patient discharge from PACU.

Exploratory Objectives:

1. To assess the primary/secondary outcomes for the English and Spanish-speaking patients separately.
2. To correlate pain-reported intensity to the analgesia nociception index (ANI).

Eligibility Criteria:
Inclusion Criteria:

1. Ages 7-17 years old,
2. Able to provide assent, and a legal guardian able to provide informed consent
3. Current diagnosis of pediatric cancer or benign neoplasm,
4. Surgery with an estimated duration longer than 2 hours,
5. An expected prescription of opioids during the inpatient perioperative period
6. Demonstrate capacity to comprehend and interact with the game in English or Spanish.

Exclusion criteria:

1. Any concerns from the principal investigator or primary team about the use of the app,
2. Inability or refusal from the parents to provide written informed consent.
Comparative Study of the Optical Biometer for Measurements of the Eye

The primary purpose of this comparative clinical study is to collect clinical data to demonstrate the equivalence of the investigational device to the predicate device for measurements of the eye. The secondary purpose is to evaluate any adverse events that occur during the clinical study.

This is a prospective clinical study to be conducted at a single clinical site located in the United States. This study will assess the agreement of an investigational device to the predicate device and an ultrasound reference device and the precision of the investigational device with a comparison to the precision of the predicate. Any adverse events associated with the investigational device can or the predicate device will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who can follow the instructions by the Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on scheduled examination dates.
2. Subjects who sign an informed consent form to participate in the clinical trial.
3. Subjects who agree to take the qualifying eye examination and a series of devices measurements.
4. Subjects able to fixate on a target.
5. Subjects must meet at lease one of the following criteria:

   * Normal eyes: Subjects with a natural lens without a cataract, corneal abnormalities or prior keratorefractive surgery.
   * Eyes with Cataracts: Subjects with a pre-existing cataract without corneal abnormalities or prior keratorefractive surgery.
   * Eyes without a Natural Lens: Subjects that are pseudophakic or aphakic without corneal abnormalities or prior keratorefractive surgery.
   * Eyes with Corneal Abnormality: Subjects with a corneal abnormality and a natural lens without a cataract, or Subjects post keratorefractive surgery and a natural lens without a cataract.

Exclusion Criteria:

1. Pregnancy.
2. Any eye condition preventing use of any of the instruments used in the study.
3. Any eye condition which might impair the validity of results from any of the instruments used in the study.
4. Any medical condition, which, in the Investigator's judgment, interferes with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.