cyrilzakka/clinical-trials huggingface dataset:
Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)

The goal of this randomised controlled trial is to evaluate the effect of a postoperative rehabilitation program after surgical correction of abdominal rectus diastasis. The main questions to answer are:

1. Does structured postoperative abdominal exercise improve abdominal wall function in three months and twelve months after surgical correction of abdominal rectus diastasis
2. Does connective tissue components differ in patients with abdominal rectus diastasis when compared to healthy individuals?

The investigators want to include patients in Sweden that are eligible for surgical correction of their abdominal rectus diastasis. Patients will be recruited at the surgical clinic at four hospitals in Sweden. After being informed about the study and potential risks, all patient give written informed consent. Randomisation is performed upon inclusion.

All patients undergo surgery by plication of the linea alba. A blood sample is collected prior to the surgery. During the surgery the skin, connective tissue and rectus muscle are biopsied. On the first postoperative day, another blood sample is collected. Follow up is conducted three and twelve months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diastasis \> 3 cm
* At least 1 year since child birth
* One year of steady weight after weightloss
* BMI \< 30
* Males with diastasis above and below umbilicus

Exclusion Criteria:

* New planned pregnancy
* Smoker
* Connective tissue disease
* Immunosuppressive treatment
* Umbilical hernia \> 2 cm
Screening for Gynecologic Cancers in Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Patients

Among women with HNPCC, this study will assess:

1. Knowledge of screening recommendations for endometrial and ovarian cancers.
2. Perceived risk and cancer worries regarding endometrial, ovarian and colorectal cancers.
3. Adherence to screening recommendations for endometrial, ovarian and colon cancers.
4. Perceived benefits,supports and barriers to endometrial and ovarian cancer screening.
5. Patterns of communication about endometrial and ovarian cancer risk within families with HNPCC and with health care providers.
6. Patient preferences for potential cancer screening and cancer prevention strategies related to HNPCC-associated cancers.

Women who are at risk for HNPCC will be recruited to participate in this pilot study.

Women will be invited to participate in the study either through a mailed invitation or during a visit to M.D. Anderson for clinical services or for research purposes.

Women who wish to participate in the study will complete an informed consent, and will subsequently schedule an appointment with a research coordinator to complete the study questionnaire by telephone.

Eligibility Criteria:
Inclusion Criteria:

1. Being female
2. Being 25 years of age or older
3. Having an HNPCC-predisposing mutation and/or having a family history of cancer that meets the Amsterdam or Amsterdam II criteria for HNPCC

Exclusion Criteria:

1. Persons who have tested negative for a known HNPCC-predisposing mutation in their family
2. Persons who have no family HNPCC mutation and have not met the Amsterdam I/II criteria
3. Being younger than 25 years old
4. Note: Women who have had a prior history of colorectal cancer or polyps will not be excluded unless they meet one of the above exclusion criteria.
Translating Habituation Research to Interventions for Pediatric Obesity

The purpose of this center grant is to translate basic behavioral science on habituation theory into clinical intervention using a vertical hierarchical approach from laboratory studies to field studies to the clinical intervention to improve weight loss outcomes in pediatric obesity treatment.

Habituation is one factor that may be related to excess energy intake. Research has shown that the rate of habituation is inversely related to the amount of food consumed and slower habituation may be a factor that is relevant to obesity, as overweight youth and adults habituate slower and consume more energy than their peers. Habituation is a basic form of learning that is observed in many response systems. We believe that habituation is an important process that mediates food regulation during a meal and across meals. However, there has been no research in children that translates basic research on habituation to food into clinical interventions for pediatric obesity. In the first phase, we will implement a series of laboratory studies to assess the effects of stimulus specificity and variety and the simultaneous reduction of variety for high energy density foods on short (within meal) and long-term (across meal) habituation. The second phase is designed to implement a series of field studies that will extend basic research from the first phase as well as define the optimal interval for reducing variety to facilitate long-term habituation to high energy density foods in the natural environment. The third phase is designed to develop and pilot test a family-based behavioral intervention for children that incorporates findings from phase2 into a clinical intervention.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 8-12 years of age
* At or above 85th BMI percentile
* Children must eat almost all meals with the exception of school lunch with the family.
* Overweight parent

Exclusion Criteria:

* Children who do not like the study foods, who are allergic to the study foods or who are on special diets and cannot consume the study foods.
* Families with children with a co-morbid psychiatric diagnosis or parents who are depressed, have schizophrenia, substance abuse or a history of eating disorders.
* The parent and child must not have any physical restrictions that would preclude them from making the requisite behavioral changes.
* Children must be able to read at a 3rd grade reading level and must be able to demonstrate the ability to keep dietary and activity records in a stimulated interview.
ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

Mindfulness Training specifically for pain to be offered to migraine patients

Patients with high frequency migraine will be randomized to UC or intervention. Those in intervention will attend a multi session training on Acceptance and Commitment Therapy. All participants will track responses.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18-65
* Diagnosis of episodic migraine (according to International Classification for Headache Diagnosis criteria)
* 4-14 migraine days per month over the past 3 months
* No change in medication in the past 3 months
* Greater than 1 year of migraines
* Agreeable to participate, commit to all study procedures and to be randomized to either group
* Fluent in English

Exclusion Criteria:

* Any unstable medical or psychiatric conditions requiring immediate treatment or could lead to difficulty complying with the protocol
* Active suicidal ideation
* Moderate to severe depression
* Current alcohol or substance abuse
* Recent Cognitive Behavioral Therapy, Mindfulness Based Cognitive Therapy, Dialectic Behavioral Therapy or Acceptance and Commitment Therapy within past 3 years
* Current use of narcotics
* Psychiatric hospitalization within past year
* Comorbid pain condition rated as more painful than migraine
* Starts new migraine treatment during study
* Inability to complete study visits
Clinical Pregnancies After Cryopreservation of Donor Oocytes With an Open or Closed Device

This randomized pilot study will assess if there is a difference in clinical pregnancies using donor oocytes cryopreserved in either a closed or a semi-closed vitrification device.

Oocyte cryopreservation was optimized by the use of a new technique: vitrification. Vitrification can be performed using either open devices (where the oocytes are in direct contact with the liquid nitrogen) or closed systems (where the oocytes are never in contact with liquid nitrogen). Previous studies have associated the use of open devices to higher oocyte survival rates and better embryo development. However, any beneficial effect on clinical pregnancy rates is yet to be proven. Hence, the objective of this study is to compare the clinical pregnancy rates of open and closed oocyte vitrification devices.

Eligibility Criteria:
Inclusion Criteria:

* this is a pragmatic randomized clinical trial. Hence, all consenting oocyte recipients will be eligible for the study

Exclusion Criteria:

* women who do not consent or that cannot comprehend the investigational nature of the study
Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation

The present study will utilize esophageal manometry to measure the presence and magnitude of persistent patient effort during lung protective ventilation, allowing identification and mitigation of occult lung stress.


Eligibility Criteria:
Inclusion Criteria:

* Intubated with a diagnosis of ARDS and expected to be ventilated for ≥ 48 hours
* Meets Berlin criteria for ARDS, with or without underlying chronic lung disease
* Triggering breaths on the ventilator
* Treating medical team agrees with patient participation

Exclusion Criteria:

* Known or suspected esophageal abnormalities, craniofacial abnormalities, or upper GI bleed
* Shock that requires ≥ 2 vasopressors
* pH on arterial blood gas ≤7.25
* Minute ventilation ≥ 14L/min
* Known or suspected pneumothorax, pneumomediastinum, and/or subcutaneous emphysema
* Severe ARDS with P/F ratio \<60
* Pregnancy
* Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
* Decision to withhold life-sustaining treatment
* Patients who are not expected to survive for 24 hours
* Lack of informed consent
Ganaxolone Expanded Access Program Compassionate Use

The primary objective is to provide GNX to patients ≥ 2 years with CDD-related seizures who are refractory to, or intolerant of, standard therapy.

This is a multi-center, long-term, open-label, expanded access protocol of adjunctive GNX treatment in children, adolescents, and adults with CDD. Patients with inadequate seizure control on their current anti seizure medications at therapeutic doses will be eligible for enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Molecular confirmation of a pathogenic CDKL5 variant, early onset, difficult to control seizures, and neurodevelopmental impairment are required. Male or female patients aged ≥ 2 years. In the opinion of the investigator, the patient has inadequate seizure control on current anti-seizure medications at therapeutic doses.

Exclusion Criteria:

-
Prediction of Postoperative Visual Acuity in Cataract Patients Using a Macular Optical Coherence Tomography-based Deep Learning Method

The purpose of this study is to collect the macular OCT images and preoperative and postoperative visual acuity of cataract patients who had been operated in the eye center of the Second Affiliated Hospital of Zhejiang University Medical College, and to train a model that can relatively accurately predict the postoperative visual acuity of patients by deep learing.


Eligibility Criteria:
Inclusion Criteria:

* Senile cataract patients, with or without macular disease, the impact of cataract on vision has affected the daily life of patients.

Exclusion Criteria:

* Glasses can obviously improve eyesight
* In addition to macular disease, combined with other eye diseases that seriously affect vision, resulting in no significant improvement in postoperative vision
* Complicated cataract surgery due to trauma and other reasons
* Combined with other eye diseases not suitable for intraocular lens implantation
* Patients with systemic diseases who cannot tolerate surgery
Endoscopic Findings of Gastritis in Children

Gastritis defines any (histologically confirmed) inflammation of the gastric mucosa

Gastritis is a very common disease in children. The main presentation of children with gastritis is recurrent abdominal pain and dyspepsia or vomiting. Young children may have hematemesis or melena as presentation. Drug induced or food related gastritis presents usually with acute symptoms but Helicobacter pylori gastritis have mainly recurrent abdominal pain and dyspeptic symptoms. Other presentations include diarrhea, constipation, flatulence, bloating, fatigue, low energy level, weight loss, muscle loss, bad breath etc.

The main causes of gastritis are infections, inflammation and other disorders affect the gastric mucosa in pediatric patients. Helicobacter pylori infection is the most common cause of gastritis in children which is also responsible for the majority of duodenal ulcers.

Acute erosive gastritis is most commonly the result of metabolic stress or drug or corrosive injury.

Other major causes of gastritis include celiac disease, allergic disorders, and Crohn's disease .Medication as NSAIDs, uremia, ischemia, shock, radiation, sepsis, trauma, severe burns and surgery.

Endoscopic pictures in acute gastritis may be in the form of:

* Multiple round-shaped severe erosions with a diameter of several millimeters.
* Mucosal edema, hyperemia.
* Peptic ulcer While in chronic gastritis is variable. Affects the antrum in the beginning and advances to the proximal in time .

Eligibility Criteria:
Inclusion Criteria:

* All children diagnosed as gastritis by upper endoscopy and bio gastric biopsy

Exclusion Criteria:

* • All children underwent upper endoscopy during the study period not diagnosed as gastritis
Active Pharmacovigilance of Anti-cancer Medicines

Pharmacovigilance (PV), defined by the World Health Organization (WHO) as the "science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problem", aims to improve patient safety and quality of life. There are several objectives of PV, starting with the collection and management of safety data, to promote the safe and effective use of medicines. PV also aims to provide information on drug safety to health professionals and patients, and it contributes to updating drug labels. Finally, it is active in risk management, risk minimization and the prevention of adverse effects and other drug-related problems. As defined by WHO, an adverse event (AE) is "any untoward medical occurrence that may be present during treatment with a medicine, but which does not necessarily have a causal relationship with this treatment". When there is a causal relationship with the treatment, an AE is classified as an adverse drug reaction (ADR). The collection and reporting of AEs is a process that starts from the drug development phase and proceeds continuously throughout the life cycle of the drug, and it aims to assess the benefits-to-toxicity ratios (in other words, the safety and efficacy) of all medicines. Reports of ADRs must accurately describe the case and be meaningful to health professionals worldwide. The aim of this project is to evaluate the impact of an active prescription surveillance of anti-cancer drugs carried out by the clinical pharmacist in pediatrics and young adults.


Eligibility Criteria:
Inclusion Criteria:

* patients aged \<25 years;
* receiving cytotoxic, targeted-therapy, immunotherapy drugs for the treatment of solid and hematologic cancers
* giving consent to study participation

Exclusion Criteria:

* presence of cognitive problems
Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

The hypotheses of this study are: In the older population with knee OA,

* When acupoints are chosen for both sleep and pain, there are additive effects on sleep improvement and pain relief (i.e. no interaction).
* Main effects of acupuncture on sleep improvement and pain relief are anticipated when acupoints are separately targeted for sleep and for pain, respectively.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with knee osteoarthritis, diagnosed by the ACR clinical diagnosis criteria for idiopathic OA, with at least Kellgren and Lawrence grading II and above. AND,
2. Present with knee pain at least half of the time. AND,
3. Complain of sleep disturbances associated with knee OA, with Pittsburgh Sleep Quality Index \> 5 \[36\].

Exclusion Criteria:

1. Patients with diagnosis of obstructive sleep apnea (OSA). OR,
2. Patients with dense hemiplegia secondary to cerebrovascular accident. OR,
3. NYHA Class III - patients with heart failure condition limited by minimal activity. OR,
4. Severe COPD with shortness of breath at minimal exertion. OR,
5. Peripheral vascular disease with severe claudication. OR,
6. Dementia with Mini Mental Status Exam score of 20 or less. OR,
7. Patients who received knee intra-articular corticosteroid injection within 4 weeks prior to the study or who received acupuncture treatment within 6 months. OR,
8. Unwilling to come off narcotic pain medication. OR,
9. History of bleeding diathesis or currently on anticoagulation. OR,
10. Patients currently engaged in medical legal cases related to OA or disability.
A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb

The purpose of this study is to determine if the measurement of pressure pain thresholds, in patients suffering osteoarthritis of the thumb, can be used to assess the activity of potential analgesic agents after a single dose. The study will use agents known to give pain relief in osteoarthritis as positive controls. These agents are: tramadol, naproxen and oxycodone.


Eligibility Criteria:
Inclusion Criteria:

* The clinical diagnosis of osteoarthritis of the hand, of at least 6 months duration.
* Pain around one of the thumb joints due to osteoarthritis. The patient must report the average pain in this joint, in the week prior to screening, as at least 5 on an 11-point numerical pain rating scale at the time of screening.
* The patient must demonstrate pressure pain at a thumb joint by reporting a pressure pain threshold lower than 300 kPa.

Exclusion Criteria:

* Pregnant (as judged by a urine pregnancy test) or lactating female.
* Other severe pain which may impair the assessment of the pain due to osteoarthritis.
* Skin condition over the thumb joint, which will be used for pain threshold testing, that could interfere with the assessment of pain thresholds.
* Known hypersensitivity to oxycodone, NSAIDS or tramadol.
* Patients in whom NSAIDS, oxycodone or tramadol are contraindicated, or patients taking any concurrent medications which are contraindicated with any of the study medications .
* An estimated renal clearance of less than 30 mL/min based on the Cockcroft Gault equation.
* Use of prohibited medications as listed below, in the absence of appropriate washout periods:
* Oral or intramuscular corticosteroids within 4 weeks prior to screening.
* Monoamine oxidase inhibitors within 2 weeks of screening.
* Analgesic agents, other than aspirin, or acetaminophen within 1 week prior to screening. (Aspirin use less than or equal to 325 mg per day for cardiovascular prophylaxis is permitted)
* Acetaminophen up to 4 g/day may be used, provided it is not used in the 24 hours prior to any assessment of pain thresholds.
* Intra-articular steroid injections into the study joint within 12 weeks, or to any other joint within 4 weeks, prior to screening.
* History of chronic constipation, or of any condition which, in the opinion of the investigator, may put the patient at increased risk of respiratory depression.
Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes

Project CONNECT ("Community-based Organizations Neighborhood Network: Enhancing Capacity Together") is a randomized controlled trial that involves 22 community-based organizations (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the intervention group using a constrained cluster randomization process. The remaining 11 are a part of the control intervention group. The intervention is a co-developed set of IT tools hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care facilities and CBO clients.

see above

Eligibility Criteria:
Inclusion Criteria:

Community Based Organization; 501-C3 status; Located within zip codes surrounding Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center; Provides direct services to clients

Exclusion Criteria:

Part of Johns Hopkins Medicine or Baltimore City Agency
Safety of Remifentanil Infusion

The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated.

In all patients (control group and remifentanil group induction of anesthesia will be achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil (1-4 ng/mL) by TCI target controlled infusion, and desflurane . Throughout the surgery hemodynamic parameters are going to be recorded. As soon as the surgery has been finished, in control group remifentanil infusion and desflurane inhalation is going to be stopped.In remifentanil group,desflurane inhalation is going to be stopped and remifentanil infusion will be maintained until the removal of LMA. During the emergence period the time of eye opening, hemodynamic parameters and emergence quality (score 1-2)are going to be recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II status
* aged 18-60 years old
* presenting for ureterorenoscopy

Exclusion Criteria:

* history of hypertension
* asthma and chronic obstructive lung disease
* recent respiratory tract infections
Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient

The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose.


Eligibility Criteria:
Inclusion Criteria:

1. Males 18 to 55 years old, inclusive, at the time of informed consent.
2. Must weigh between 50 kg and 110 kg, inclusive.
3. Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive.
4. All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
5. Must be a non-smoker, and no use of chewing tobacco, for at least 6 months prior to Day -1.
6. Must have a screening physical examination and ECG without any clinically significant abnormality (as determined by the Investigator).

Exclusion Criteria:

1. History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
2. History of severe allergic or anaphylactic reaction.
3. History of any clinically significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator.
4. Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
5. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.