cyrilzakka/clinical-trials huggingface dataset:
Neuroimaging of the Effects of Concerta in the Treatment of ADHD

A number of brain regions have been down to be altered in both structure and function in patients with ADHD, including prefrontal cortex, anterior cingulate, caudate and cerebellum. Patients with ADHD often show reduced levels of activity in the frontal and cingulate regions of brain while performing measures of inhibitory control during functional magnetic resonance imaging (fMRI). While stimulant medications robustly improve the clinical symptoms of ADHD, there are only a small number of studies examining the effects of these commonly prescribed medications on brain activity. We propose to obtain fMRI in patients with ADHD on placebo and on their individualized dose of OROS methylphenidate (Concerta). Our hypothesis is that Concerta will increase the activity of the brain in the frontal, cingulate and amygdala of the brain and that these brain changes will be associated with clinical improvement of symptoms.

Three age groups of subjects will be studied: school age children (aged 9-12), older adolescents (age 15-17 years) and young adults (age 20-25 years). Twenty subjects will be studied in each group. All subjects must meet criteria for ADHD, combined type and be either treatment naïve or currently taking and responding well to Concerta. Child and adolescent patients taking Concerta will have their current levels of ADHD symptoms assessed with the Dupaul ADHD rating scale (11); adults taking Concerta will be assessed with Conners Adult ADHD Rating Scale (CAARS). Patients whose symptoms are in remission as evidenced by scores in the normal range on these scales may proceed directly to the neuroimaging portion of the study. Subjects who are treatment naïve or are treated but are not in remission shall under a three week open label trial of Concerta to determine the optimal dose for treatment of their symptoms.

Subjects will have two fMRI sessions on different days. During each fMRI session, they will perform both the Stop Signal Task and the Emotional Conflict Resolution Task . On the morning of the scan, placebo and Concerta will be administered in a double-blind, crossover design, with order of medication and placebo randomized. The scan sessions will take place between 3 and 7 hours after medication administration. After each scan, the subject and a research assistant will go to a quiet room in the imaging center; the subjects will be given arithmetic level set at a level of difficulty that the subject has mastered. The subject will be given 15 minutes to complete as many problems as possible.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for Attention Deficit Hyperactivity Disorder
* Current clinical responder to Concerta (OROS-methylphenidate)

Exclusion Criteria:

* IQ \< 95
* Presence of Learning Disorder
* Presence of an Affective or Psychotic Disorder
* Presence of a Substance/Alcohol Abuse/Dependence Disorder
* Presence of an Autism Spectrum Disorder
* Presence of a Tic Disorder
* Taking any psychotropic medication other than Concerta
* A medical condition requiring daily medication
* Previous adverse or non response to Concerta
Facilitators to Keeping Colonoscopy Appointments

To identify patients at risk for nonattendance to their first scheduled colonoscopy and to conduct a randomized trial of a theory-based, peer coach intervention on completing the scheduled colonoscopy.

The potential to reduce the morbidity and mortality from colorectal cancer, the second most common cause of cancer death in the U.S. has been compromised because only about half of eligible patients have been appropriately screened. Patients contribute to inadequate colorectal cancer screening by failing to complete ordered tests. Several studies have reported low rates of attendance to scheduled sigmoidoscopy and colonoscopy studies. Because physicians offer limited counseling when ordering these tests, approaches are needed to address patient concerns and to promote adherence to scheduled colon studies. Therefore, we conducted a trial of a theory-based telephone intervention by patient 'peer coach' who was trained to address barriers to colonoscopy attendance versus a mailed professional brochure. The support was targeted to those at greatest risk of non-attendance.

Eligibility Criteria:
Inclusion Criteria:

* Age 50
* No prior colonoscopy in our health system records
* Patient in one of four primary care clinics within the University of Pennsylvania Health System
* Attended \<75 of their primary care physicians visits within the past year

Exclusion Criteria:

* Colonoscopy not ordered by a primary care physician in a study clinic
* High readiness for the procedure
* A health care professional
* Had a prior colonoscopy outside of our health care system
Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort

This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).

This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases)

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years to 100 years (adult).
* Sexes: all
* Healthy volunteers: no
* Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).

Exclusion Criteria:

-
Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study

The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).

The study has been completed.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of AIS
2. Age ≥10 years
3. Risser sign 0-2
4. Cobb's angle 20 deg to \<25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to \<30 deg

Exclusion Criteria:

1. History of treatment of AIS
2. \>= 1 year postmenarchal (for girls only)
3. Physical or mental disability to adhere to bracing
4. Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
5. Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
6. Difficulty to read, understand, and complete the study questionnaires
7. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Narrative Exposure Therapy Versus Group Interpersonal Psychotherapy

The present study is a pragmatic trial that investigates the efficacy and usefulness of two treatment modules in a sample of Rwandan genocide orphans: Narrative Exposure Therapy (NET) versus group-Interpersonal Psychotherapy (IPT). We used a half year baseline to measure the treatment-induced changes. We hypothesized that there would be a greater reduction in posttraumatic stress symptoms in the NET- than in the IPT-group and that IPT would be superior to NET in the reduction of depression symptoms.

The 1994 genocide of Rwanda has left countless children orphaned. 26 Rwandan orphans who fulfilled DSM-IV diagnosis of PTSD were offered participation in a controlled treatment trial. A group adaptation of Interpersonal Psychotherapy (IPT, n = 14) was compared to Narrative Exposure Therapy (NET, n = 12). Main outcome measures were symptoms of PTSD and depression assessed pre-treatment, 3 months after therapy (post-test) and 6 months after therapy (follow-up) using the CAPS, MINI and Hamilton Rating Scale. At post-test, participants in both treatment conditions showed reductions in posttraumatic stress symptoms and depression symptoms. At 6-month follow-up, NET proved to be more effective in the treatment of PTSD. Only 25% (n = 3) of NET-participants but 71% (n = 10) of the IPT-participants still fulfilled PTSD criteria at follow-up. Although there was a significant reduction in depression symptoms in both treatment groups from pre-test to follow-up, NET again proved to be more effective. This treatment-trial demonstrates that NET and group-IPT are suitable treatment modules even when most severe traumatic stress and difficult living conditions have led to chronic mental suffering.

Eligibility Criteria:
Inclusion Criteria:

* Rwandan orphans who have experienced the genocide, who lost at least one parent during the genocide and who were no older than 18 years during the genocide

Exclusion Criteria:

* Mental retardation
* Psychotic symptoms or current drug or alcohol
Safety and Viability of an E. Coli Nissle Colibactin Knockout in Healthy Volunteers

E. coli Nissle (EcN) is a well-established human probiotic. However, it has been found that it produces colibactin, linked to colorectal cancer. In this safety trial, the safety and properties of a novel, colibactin-knockout EcN strain (EcNΔClbP) is investigated.

In this randomised controlled intervention study, the investigators will compare EcN vs. EcN colibactin-knockout (EcNΔClbP), given once daily for 7 days, in a population of healthy individuals. Safety will be established using adverse event reporting, study visits and laboratory parameters. Pharmacokinetics will be established at the beginning and the end of the study. EcN/EcNΔClbP gut engraftment properties and effects on gut microbiome composition will be assessed using fecal analyses (qPCR, shotgun metagonmics). In addition, effects on glucose homeostasis will be studied using continuous glucose monitoring.

Eligibility Criteria:
Inclusion criteria:

* Healthy male or female of Caucasian descent

  * If female, postmenopausal
* Age: 18-65 years old
* BMI: 18-25 kg/m2
* Subjects should be able to give informed consent

Exclusion Criteria:

* Use of any systemic medication (except for paracetamol), including proton pump inhibitors, antibiotics and pro-/prebiotics in the past three months or during the study period.
* Use of the EcN probiotic strain (Mutaflor®) in the past 12 months.
* (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic chemotherapy or human immunodeficiency viruses (HIV) infection with a CD4-T cell count \< 240/mm3).
* History of moderate to severe disease of the digestive tract, such as celiac disease, chronic diarrhoea (≥3 stools/day for \>4 weeks), chronic obstipation (\<2 defecations/week for \>3 months), Irritable Bowel Syndrome (IBS) (according to Rome IV criteria) or Inflammatory Bowel Disease (IBD).
* Any gastro-intestinal disorder within the past 6 months
* Smoking or illicit drug use (e.g. amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
* Use of \>21 units of alcohol per week on average in the past three months or use of \>2 units of alcohol during the study period.
* Simultaneous participation in other studies
Effects of Antenatal Exercises in Primagravida

The goal of this Randomized control trial is to determine the effects of antenatal exercises on low back pain in Primagravida. The main questions it aims to answer are whether supervised antenatal exercises have an effect on low back pain and depression in primagravida.

Females usually tend to avoid physical activity during pregnancy. Concept of antenatal exercises and its effects on low back pain or antenatal depression is yet not common amongst pregnant females in Pakistan. Low back pain and antenatal depression are common in pregnancy. These can have an impact on both their own health and the health of their unborn child. Understanding the benefits of antenatal exercises will encourage pregnant females to engage in regular physical activity. The results of this study will help physical therapists to implement effective exercise interventions for this population.

Eligibility Criteria:
Inclusion Criteria:

* Primagravida
* Single pregnancy
* Diagnosed for risk of Prenatal depression on EDPS \>10
* Pregnancy related Low back pain score of 3 to 8 on NPRS for at least 2 weeks.
* Females in 2nd Trimester of pregnancy

Exclusion Criteria:

* Any present or previous pelvic floor dysfunctions diagnosed by health professionals.
* Any physical disability causing inability to perform physical exercises.
* Any contraindications to physical activity according to ACOG
* Pelvic girdle pain (Anterior: Pubic symphysis, Posterior: SI joint Pain, Gluteal Pain, Piriformis syndrome).
* Rheumatoid disorders.
* Low back pain with radiation
* Not engaged in regular exercise.
Topical Tacrolimus in Vernal Keratoconjunctivitis

The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis.

A total of 20 patients with bilateral symmetrical vernal keratoconjunctivitis will be included. Each patient will undergo a complete ophthalmologic evaluation. Patient will be placed at random on topical Tacrolimus 0.01% ophthalmic solution in one eye and placebo eyedrops in the fellow eye. Patients will undergo ophthalmologic examination at one week and after one month. Photos will be taken. The outcome measures include graded symptoms, graded signs, and laboratory investigations. Symptoms of itching, redness, foreign body sensation, tearing and discharge following will be recorded before and after treatment. The grading of clinical signs of conjunctival hyperemia, conjunctival papillary hypertrophy, perilimbal infiltrates, Trantas dots, superficial punctate keratopathy will be recorded before and after treatment. Conjunctival surface temperature will be determined before and after treatment. Conjunctival scrapings will be stained with Giemsa and will be assessed before and after therapy and number of eosinophils per hpf will be determined and recorded.

Eligibility Criteria:
Inclusion Criteria:

* with bilateral symmetrical palpebral and limbal vernal keratoconjunctivitis
* Patients 6-18 years of age

Exclusion Criteria:

* Pregnant patients
* Patients on systemic therapy for other allergic disorders
* Patients who cannot come for follow-up
* Patients who are on other topical medications for other comorbid ocular conditions
Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft

To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.

AIM To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.

PRIMARY OBJECTIVE

Horizontal and vertical dimensional changes of extraction sockets as evaluated in a CBCT scan immediately post extraction and 6 months post extraction when grafted with xenograft versus allograft.

SECONDARY OBJECTIVE

1. Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
2. Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
3. Difference in histologic analysis of bone biopsy cores taken in xenograft and allograft groups at 6 months re-entry from osteotomy site.

Difference in newly regenerated supracrestal bone height and volume will be measured directly from the segmented images from MicroCT.

NULL HYPOTHESIS

There is no difference between the two groups for any of the parameters evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥ 21 years of age
2. Able to provide informed consent
3. Good general oral health (no active periodontal disease, absence of hopeless teeth, absence of active caries, absence of acute infections)
4. Single rooted non molar teeth needing extraction for miscellaneous reasons (since histological analysis is being done, it is essential to harvest bone core biopsies without inclusion of native bone16)
5. Presence of natural teeth adjacent to the tooth planned for extraction
6. Absence of acute signs of infection such as pus discharge, fistulous tract and / or abscess in relation to tooth being extracted
7. Dehiscence type defects of the sockets limited to 2/3rd length of the root

Exclusion Criteria:

Systemic conditions

1. Conditions and circumstances as evaluated by investigator that would prevent completion of study participation
2. Conditions requiring chronic routine use of antibiotics or steroids
3. History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infections
4. Alcoholism or drug abuse and heavy smokers \>10 cigarettes a day
5. Simultaneous participation in other studies
6. Pregnancy - Patients pregnant before the start of the study or patients who become pregnant during the course of the study

Local conditions

1. Untreated periodontitis, caries or presence of hopeless teeth (other than the one planned for extraction)
2. Multi rooted teeth
3. Irradiation therapy
4. Osseous lesions
5. Missing teeth adjacent to the tooth being extracted
6. Implant restorations adjacent to the tooth being extracted
7. Multiple socket walls missing following extraction or buccal dehiscence defect extending to the apex of the root
Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

The purpose of this study is to develop a novel noninvasive bedside optical coherence tomography (OCT) imaging technique in newborn infants with HIE that improves our ability to assess the range of retinal effects from HIE and to diagnose and monitor treatments of HIE.


Eligibility Criteria:
Inclusion Criteria:

Infants are eligible if:

* Admitted to the intensive care nursery, outborn or inborn, with a clinical diagnosis of HIE; and with the approval of the neonatologist
* A parent or legal guardian provides written informed consent

Exclusion Criteria:

Potentially eligible infants will be excluded if:

• Congenital or chromosomal anomaly that has a profound impact on brain or eye development (e.g. anencephaly, congenital cataract or Peter's anomaly) and infants for whom there has been a clinical decision to limit life support.
Real-Time Identification System of Magnetically Controlled Capsule Endoscopy Using Artificial Intelligence

The aim of this study is to evaluate the performance of real-time auxiliary system based on artificial intelligence algorithm in lesion detection and quality control in magnetically controlled capsule endoscopy.

Magnetically controlled capsule endoscopy (MCE) has been used in clinical practice for gastric examination, with high sensitivity and specificity of 90.4% and 94.7%, respectively.

Therefore, a real-time auxiliary system based on convolutional neural network deep learning framework was developed to assist clinicians to improve the quality in MCE examinations.

Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating center were prospectively enrolled. After passage through the esophagus, physician will finish the gastric examination under magnetic steering with the real-time auxiliary system. Professional operators guarantee the integrity of the examination and the diagnostic results of professional endoscopist was used as the gold standard. The system diagnosis results was recorded at the same time. The sensitivity, delay time, specificity of lesions and anatomical landmarks will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* With or without gastrointestinal complaints
* Scheduled to undergo a capsule endoscopy for both stomach and small bowel
* Signed the informed consents before joining this study

Exclusion Criteria:

* Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
* Refused abdominal surgery to take out the capsule in case of capsule retention
* Implanted pacemaker, except the pacemaker is compatible with MRI
* Other implanted electromedical devices or magnetic metal foreign bodies
* Pregnancy or suspected pregnancy
Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women

To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.


Eligibility Criteria:
Inclusion Criteria:

1. Naturally or surgically postmenopausal women, with or without an intact uterus, aged 50 to 75 years of age, inclusive. FSH levels greater than 40 mIU/mL

Exclusion Criteria:

1. Currently taking any estrogen/progesterone hormone replacement therapy (HRT).
2. History of allergy or sensitivity to hydroxyprogesterone caproate, castor oil or any of the constituents of the study medications, or history of any drug hypersensitivity or intolerance
3. Poorly controlled diabetes.
4. History or current evidence of deep vein thrombosis, pulmonary embolism or arterial thromboembolic disease (e.g., stroke, myocardial infarction).
5. Known, suspected, or current history of carcinoma of the breast.
6. Subjects with a past history of breast cancer on aromatase inhibitors or selective estrogen receptor modulators.
7. Known, suspected, or current history of hormone dependent tumor within the last 5 years.
8. Any current or recent (within previous 12 months) genital bleeding of unknown etiology.
9. Receipt of any investigational drug within 30 days.
10. Receipt of any prescription or OTC medications that are known to alter CYP3A4 or CYP3A5 levels (e.g., carbamazepine, St. John's Wort, ketoconazole, rifampin, ritonavir, alprazolam, azithromycin, loratadine, etc.) within 14.
11. Any estrogen, progestin, or selective estrogen receptor modulator (SERM) treatment within specified time windows before the study start, ranging from 2 to 6 months.
12. High blood pressure at the screening evaluation, defined as systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 90 mm Hg.
13. History of excessive alcohol consumption (on average more than 14 units of alcohol/week) during the past 12 months.
14. Use of tobacco products within 30 days of the start of the study.
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso

The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Burkina Faso.


Eligibility Criteria:
Inclusion Criteria:

* Having an ongoing pregnancy of 13-22 weeks gestation
* Be willing to undergo surgical completion if necessary
* Have no contraindications to study procedures, according to provider
* Be willing and able to consent to participate in the study
* Be willing to follow study procedures
* Respect legal indications for obtaining an abortion

Exclusion Criteria:

* Known allergy to mifepristone or misoprostol/prostaglandin
* Any contraindications to vaginal delivery, including placenta previa
* Previous transmural uterine incsion