cyrilzakka/clinical-trials huggingface dataset:
Ultrasound for Scoliosis Diagnostic Evaluation

Scoliosis is a complex 3-dimensional deformity of the spine. It may occur at any time throughout growth and development and is typically detected through x-ray imaging. Although effective at visualizing a curve, x-ray imaging is costly and may expose children to potentially harmful ionizing radiation. This is a 30 patient study to evaluate the reliability of ultrasound, an imaging technique without radiation, to effectively measure scoliosis deformities compared to the gold-standard of x-ray.

All patients who present to Children's National Medical Center for initial evaluation of idiopathic or juvenile scoliosis will be approached.

Eligibility Criteria:
Inclusion Criteria:

* All patients ages 7-17 years who present to Dr. Matthew Oetgen in the Department of Orthopaedic Surgery \& Sports Medicine for clinical evaluation of scoliosis,
* Scoliosis curve type to include adolescent idiopathic (AIS) or juvenile, and
* Have x-rays taken as part of clinical evaluation

Exclusion Criteria:

* Not willing or able to provide consent, or
* Had x-rays taken at an outside facility, or
* Any underlying neuromuscular condition or syndrome and congenital deformities
The Effect of Supervised Exercise on Physical Fitness and Energy Expenditure in Post Bariatric Surgery Patients

It is hypothesized that the patients in the EXDA group will be able to complete a structured exercise program at a level sufficient to accumulate at least 2000 kcal per week, and that the structured endurance activity will increase their physical fitness and total daily energy expenditure compared to the DA group.


Eligibility Criteria:
Inclusion Criteria:

1. RYGB or GB surgery patients who are at least 12 weeks post surgery
2. BMI of 40 or more
3. age 18-70years
4. sedentary lifestyle (energy expenditure of \<35 kcal/kg/day measured by 7-day physical activity recall and no regular moderate physical activity exceeding 20 min/day within the previous 3 months)
5. willingness to alter physical activity in accordance with the intervention programs
6. English or Spanish speaking.

Exclusion Criteria:

1. body weight \> 180 kg
2. cardiovascular disease
3. pulmonary disease
4. uncontrolled hypertension (resting DBP \>100 or SBP \>180 mm of Hg)
5. visual or hearing impairment
6. functional limitations (difficulty walking one-quarter mile or climbing 10 stairs)
7. abnormal ECG on VO2max test ( \>1 mm ST segment depression at \< 5 METS or with symptoms such as atrial fibrillation, complex ventricular arrhythmias and 3rd degree atrioventricular block)
8. known liver disease due to causes other than nonalcoholic steatohepatitis (liver transaminases \> 2.5 times the upper limits of normal \[SGPT\>105 U/L, SGPT\>120 U/L\] or total bilirubin \>1.5 mg/dL)
9. hematocrit of less than 30%
10. current alcohol abuse (\>7 drinks or 210 g/wk for women and \>14 drinks or 420 g/wk for men)
11. recreational drug abuse
12. current use of any drugs capable of inducing weight loss (e.g., orlistat, sibutramine, topiramate, etc.)
13. major neuro-psychiatric illnesses impeding competence or compliance
14. pregnancy and lactation
15. chronic renal insufficiency (serum creatinine \> 2 mg/dL)
16. untreated thyroid disorders such as hypothyroidism and hyperthyroidism; and 17) bariatric surgical complications including anastomotic leak, wound complications, thrombotic disorders, intestinal obstruction, stomal complications, GI bleeding, recurrent severe abdominal pain, bilious vomiting.
Vonoprazan in Helicobacter Pylori Treatment an RCT

RCT for comparison of Standard Triple therapy (Omeprazole+Amoxil+Clarithromycin) for H Pylori erradication with Vonoprazan+Amoxil dual therapy.

OBJECTIVE To compare the efficacy of Vonoprazan based dual treatment versus PPI based treatment for the eradication of Helicobacter pylori infection.

OPERATIONAL DEFINITION

Helicobacter Pylori infection: Hp infection will be labelled by any one of following investigation:

* Helicobacter Pylori Stool Antigen
* Histopathology on Giemsa Stain

MATERIAL AND METHODS:

Study Design: Randomized control trial. Setting: This study will be conducted in the Medical OPD and Medical Unit 1 of Dr. Ruth K.M. Pfau, Civil Hospital Karachi affiliated with Dow University of Health Sciences

DATA COLLECTION PROCEDURE:

All patients presenting to the OPD or Medical Unit 1 of Dr. Ruth KM Pfau, Civil Hospital Karachi and fulfilling the inclusion criteria will be included after taking informed consent.

The participants will be randomly allocated to 2 groups with help of random number table and will be treated for 2 weeks.

Group A: will be given:

Capsule Amoxicillin 1 gm twice daily Tablet Clarithromycin 500 mg twice a day Capsule Omeprazole 20 mg twice a day

Group B will be given:

Capsule Amoxicillin 1 gm twice daily Tablet Vonoprazan 20 mg twice a day Confirmation of Hp eradication will be done by stool Hp antigen test 4 weeks after completion of treatment.

DATA ANALYSIS Data will be stratified according to age \& gender. Frequency of gender \& mean (SD) of age will be compared between groups using Pearson's Chi-square test and Student's t-test respectively. Frequency of Hp eradication between two groups will be compared using Pearson's chi-square test. A p value \< .05 will be taken as significant.

Eligibility Criteria:
Inclusion Criteria:

* Helicobacter Pylori Positive by any one of following:

Histopathology by Giemsa Stain Stool Antigen

Exclusion Criteria:

* • Previous surgery of the stomach such as partial gastrectomy.

  * Allergy to any of the antibiotics used in the study.
  * Intake of antibiotics, PPIs, corticosteroids, or nonsteroidal anti-inflammatory drugs within the last 2 weeks.
  * Pregnant or lactating females.
  * Alcohol abuse or drug addiction.
  * Severe neurological or psychiatric disorder.
The Effect of Implementing Hyper-acute Stroke Guidelines on Decision-Making for or Against Thrombolytic Therapy for Stroke in the Emergency Department

The objective of this study is to determine if the implementation of guidelines utilizing immediate CT Perfusion and CT Angiography in addition to non-contrast CT alters (reduces or increases) the time to decision-making for or against rt-PA in acute ischemic stroke, and by extension, time to therapy in treated patients and time to transfer from the department for all patients. A secondary objective is to determine if using CTP/CTA-inclusive hyperacute stroke guidelines improves safety by decreasing symptomatic intracerebral hemorrhage and mortality in patients who receive rt-PA.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the emergency Signs and symptoms of acute ischemic stroke: impairment of language, motor function, cognition and/or gaze, vision or neglect.
* Patients with an NIH Stroke Scale score \> 4

Exclusion Criteria:

* Age less than 19
* Patient symptomatic for greater than five hours. Intravenous thrombolytic therapy must be instituted within three hours of symptom onset in order to minimize the risk of Intracerebral or symptomatic hemorrhage; other interventions such as intra-arterial thrombolytic therapy and clot retrieval allow for a six-hour window. One hour is an achievable time for arrival to institution of therapy, therefore a five-hour limit on enrollment allows the greatest number of patients the possibility of therapy.
* Inability to verify a clear onset of symptoms. As noted, time elapsed since the patient's last known baseline state is correlated to Intracerebral and symptomatic hemorrhage, and therapy is approved only for patients with a clear time of onset.
A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease

The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Advanced prostate cancer
* Indication to initiate androgen deprivation therapy (ADT)
* Predefined cardiovascular disease

Exclusion Criteria:

* Previous or current hormonal management of prostate cancer (unless terminated at least 12 months prior to trial)
* Acute cardiovascular disease in the previous 30 days
Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes

This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes treated with insulin for at least 12 months
* Planning to become pregnant and have a screening HbA1c (glycosylated haemoglobin) lesser than or equal to 9.0%, or
* Pregnant with an intrauterine singleton living foetus, 8-12 weeks pregnant when joining the trial and a HbA1c lesser than or equal to 8.0% when pregnancy is confirmed

Exclusion Criteria:

* Known or suspected hypersensitivity to the trial product(s) or related products
* Untreated hyperthyroidism or hypothyroidism
* Known or suspected abuse of alcohol or narcotics
* Cardiac problems
* Impaired kidney function
* History of severe hyperemesis gravidarum
* Treatment with in-vitro fertilisation or other medical infertility treatment
* Impaired liver function
* Uncontrolled hypertension
* Proliferative retinopathy or maculopathy requiring acute treatment
* Known to be HIV (human immunodeficiency virus) positive, Hepatitis B or Hepatitis C positive
* Any concomitant medication contraindicated in pregnancy
Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes

Once a pregnant mother is diagnosed with gestational diabetes mellitus (GDM), she will be treated with either diet, medication (i.e., insulin), or both. The most important factor in GDM management is glycemic control to reduce adverse outcomes. Blood glucose levels have become the "key player" for monitoring and directing treatment during pregnancy. Large trials have confirmed that treatment of GDM to optimize glycemic control can decrease the incidence of many of these associated adverse maternal and neonatal outcomes. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. However, SMBG provides an incomplete picture of the daily glucose profile due to long intervals between finger pricking, and inaccurate self-reported measurements, which heavily rely on patients' compliance.

The incidence of obesity and diabetes is rising worldwide even in younger populations. With a rise in maternal obesity also gestational diabetes mellitus (GDM) becomes more prevalent with a prevalence of up to 18% of pregnancies. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. The main purpose of this study is to prove that real time continuous glucose monitoring (rt-CGM) can effectively reduce the risk for adverse pregnancy and neonatal outcome in GDM. It is further hypothesized that rt-CGM can optimize maternal glycaemic control, increase patients satisfaction and adherence to management strategies of GDM. This is a open label randomized controlled trial with two parallel groups.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* GDM diagnosis between 24 0/7- 28 0/7 weeks of pregnancy by a 75g oral glucose test (oGTT)
* Maternal age of 18 to 45 years,
* Singleton gestation
* Gestational age ≥ 24 0/7 weeks and \<32 0/7 weeks at enrollment.

Exclusion Criteria:

* Known hypersensitivity or allergy to the sensor
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders of the participant
* Participation in another study with investigational drug or product within the 30 days preceding and during the present study
* Maternal age \< 18 years,
* Multi-fetal gestations,
* Known fetal structural or chromosomal anomalies
* Chronic use of medications associated with hyperglycemia (steroids)
* Planned preterm delivery
* Overt diabetes mellitus type 1 or 2
* HbA1c by study entry \> 6.5%
* History of bariatric surgery or other surgeries that induce malabsorption
* Fetal growth restriction by study entry
High Dimensional Analysis of Immune Cells in Pediatric Patients

The purpose of this study is to characterize immune cells using single-cell transcriptomic analysis in pediatric patients aged 2 to 18 years undergoing general anesthesia who are expected to receive Rocuronium, a non-depolarizing neuromuscular blocking agent, in the event of an allergic reaction.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients between the ages of 2 and 18 undergoing general anesthesia and surgery using the neuromuscular blocker, rocuronium.

Exclusion Criteria:

* Patients who have received immunomodulators, immunosuppressants, etc.
* Patients with autoimmune diseases (rheumatoid arthritis, lupus, Behcet's disease, etc.)
* Patients who regularly take, or have taken within 4 weeks, medications that may affect the immune system (oral steroids, anti-inflammatories, etc.)
* Other cases where the Principal Investigator determines that it is difficult to conduct the study.
Lifting Effect on Recovery After Mastectomy

Breast cancer surgery has evolved towards ever more breast conserving direction. Even thought the surgical regime has become easier for the patient, many instructions given to the patient after the operation base on instructions, which have been used when the performed operations have been more burdensome.

Previously the patients have been instructed to lift only light objects after the operation, but according to the current knowledge, this instruction might be unnecessary.

The meaning of this study is to compare two patient groups to each other. The other group is instructed to avoid lifting, and the other group is given instructions to lift light weights several times daily.

In the study we compare will this have an effect on

1. incidence of upper limb lymphedema
2. seroma formation after surgery
3. quality of patients life after the surgery

Inclusion criteria is patients underoing mastectomy but no axillary clearance on day-care basis. Patietns will be randomized in two groups, the other as an intervention group and other as an control group. The patients are asked to fill a questionnaire considering recovery from the operation and possible wound healing problems. The amount of seroma is recorded. The volume of upper limbs is measured before and after the surgery.

The study is started in January 2022 and finished in December 2024.


Eligibility Criteria:
Inclusion Criteria:

* patients with breast cancer diagnosis requiring mastectomy
* patients being operated in day-care regime

Exclusion Criteria:

* patients not eligible for day-care mastectomy
* patients undergoing axillary clearance operation
Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES).

This study aims to assess the efficacy of Epidiolex in patients with ESES. ESES is characterized by sleep potentiated spikes with a spike index greater than 85% (conventional definition) and 50% (new definition)1. Several drugs including: steroids, intravenous Gama globulin, Clobazam, other benzodiazepines, Valproic acid, and other anti-epileptic drugs have been tried with mixed benefits2,3. Cannabidiol (CBD) would provide a novel mechanism of action to assess for its efficacy in this population. This will be a double-blind placebo-controlled crossover clinical trial.

This study attempts to view the effect of Epidiolex on subjects with Electrical Status Epilepticus of Sleep (ESES). ESES can cause various types of seizures which can fluctuate during sleep. Similar studies have been conducted with Epidiolex with other seizure disorders such as Lennox-Gastaut syndrome (LGS) and Dravet Syndrome. Since there is no data available on the effect of Cannabidiol (CBD) on patients with ESES, this study hopes to fill that void. As such, patients that have been diagnosed with ESES will be eligible to participate in this study to ascertain whether or not Epidiolex can reduce the frequency or intensity of the seizures brought on by ESES during sleep.

Eligibility Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 2-17 years old
4. In good general health as evidenced by medical history or diagnosed with ESES. "Good health" in relation to this study is understood as stable without current seizures requiring immediate hospitalization.
5. Ability to take oral medication and be willing to adhere to the Epidiolex/Placebo regimen
6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 month after the end of oral Epidiolex administration
7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:An individual who meets any of the following criteria will be excluded from participation in this study:

1. Previous use of cannabidiol within 4 months.
2. Pregnancy or lactation
3. Known allergic reactions to components of the Epidiolex: cannabidiol, sesame seed oil, and sucralose
4. Febrile illness within 1 month of screening
5. Treatment with another investigational drug or other intervention within 6 months
6. Current smoker or tobacco use within 6 months
Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania

Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children living with HIV who are orphaned. This phase 2 trial aims to determine whether attending the intervention improves outcomes compared to standard care. We aim to test the hypothesis that attendance at MWT improves psychological symptoms, self-esteem, emotional and behavioural difficulties, and self-efficacy compared to standard care.


Eligibility Criteria:
Inclusion Criteria:

* Aged 14-18 years
* HIV positive
* Orphaned
* Naïve to the intervention

Exclusion Criteria:

* Adults
* Children under 14
* HIV negative
* Parent(s) living
* Previously attended the intervention
Just Kwit: Mobile Intervention for Tobacco Cessation

The intervention will be use of a smartphone app to support tobacco cessation. The app's main features include sending motivational messages, displaying money saved, and allowing the user to log cravings.

The investigators will recruit hospitalized young adult smokers aged 18-30 interested in cessation over a six-month period. Patients will all receive a UPMC Tobacco Treatment Service counseling session focused on motivational interviewing prior to participation in the study. Upon consent, participants will then be randomized 1:1 to either standard patient-initiated follow-up or use of the Kwit app. Participants will be stratified by sex because males and females are known to have highly variable responses to existing tobacco control interventions. Investigators will systematically assess feasibility using established Likert-type items factors such as interaction, features, engagement, trust, and impact.

If a participant consents to the study, they will be given a brief survey to collect general information related to their smoking behavior. After 30 days, a follow-up survey will be conducted to assess their current smoking behavior. Participants randomized to the experimental arm will be asked additional questions about their use of the smartphone app.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-30 smokers interested in cessation (\>5 cigarettes/day over the past 30 days)
* Must own an Apple or Android based smartphone.

Exclusion Criteria:

* Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation.
Prevalence and Impact in Work Productivity of Gastroesophageal Reflux Disease (GERD) in Primary Care Patients With Upper Gastrointestinal (GI) Symptoms Using GerdQ

The purpose of the study is to provide data on the GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire. Furthermore the study aims to estimate GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire, to observe possible variations between the two methods (physicians' symptom rating and GerdQ), to objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment. Finally, to describe the impact of GERD symptoms on work productivity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with upper-GI symptoms the last week prior visiting the investigator

Exclusion Criteria:

* History of oesophageal, gastric or duodenal surgery
* Treatment with NSAIDs/Acetylsalicylic acid within the last week prior to the study visit
* PPI use for healing of NSAIDs induced ulcer or for HP eradication