cyrilzakka/clinical-trials huggingface dataset:
A Study of Entresto in Tetralogy of Fallot (TOF) and Ebstein's Anomaly (EA)

The purpose of this study is to compare changes in RV structure and function, biomarkers, and patient reported outcomes between TOF patients randomized to an ARNI vs placebo.


Eligibility Criteria:
Inclusion Criteria:

* TOF or EA
* Age 18 or Older

Exclusion Criteria:

* Stage IV chronic kidney disease defined as creatinine clearance \<30 ml/min
* Hyperkalemia defined as serum potassium \>5.2 mmol/l,
* Hypotension defined as systolic blood pressure \<100 mmHg,
* History of angioedema related to previous ACE or ARB therapy
* Patients diagnosed with diabetes using Aliskiren,
* Pregnancy.
* Drug Therapies

  * Amifostine
  * Droperidol
  * Dantrolene
  * CYP3A4 Inhibitors
  * Obinutuzumab
  * Aliskiren
  * Lithium
  * Sparsentan
  * ACE inhibitor
  * ARB
  * ARNI
Effectiveness of Fascial Manipulation in Rotator's Cuff Surgery Patients

The purpose is to evaluate the effectiveness of fascial manipulation treatment in terms to reduce pain and improve physical functionality after rotator's cuff surgery. The technique involves deep friction manipulation of fascia's specific spots. Distant from surgical site.

To evaluate the effectiveness of fascial manipulation treatment associated with standard physiotherapies treatment in rotator's cuff surgery patients, we'll randomize about 60 patients for arm's of study. Both arm's will receive 10 standard physiotherapies treatments in 2 weeks while the experimental arm will receive 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.

To evaluate the effectiveness of fascial manipulation treatment we'll use 2 type of outcome measure and we will compare the result of both arms of study.

Eligibility Criteria:
Inclusion Criteria:

* Rotator's cuff surgery patients that have been operated within the past 4/5 weeks
* Age between 18 to 65 years old

Exclusion Criteria:

* Patients with traumatic shoulder's injury that involved bone's fractures.
* Severe underlying pathologies like rheumatic, neurological and cardio pathologies that affect the correct shoulder treatment
* Patients on anticoagulant treatment
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a pre-menopausal female 20 to 49 years of age.
* Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:

  * At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound.
  * Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).
  * Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements.
* Subject has a history of regular menstrual cycles between 24 to 35 days.
* Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss \> 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method.

Exclusion Criteria:

* Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation.
* Subject has a history of osteoporosis or other metabolic bone disease.
* Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.
* Subject has a history of clinically significant condition(s) including but not limited to:

  * Endometriosis
  * Epilepsy or seizures
  * Type 1 diabetes
  * Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment

This post-market registry aims to assess safety and performance of RefluxStop™ in the treatment of Gastroesophageal Reflux Disease (GERD) in standard of care procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent and to participate in the registry study,
2. Patient's age ≥ 18 years or according to local legal age of adulthood if older,
3. Documented GERD present for \> 6 months,
4. Patient has a 24-hour pH monitoring proven GERD with pH and/or impedance pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be \<4 for \>4.5% of time during a 24-hour monitoring and/or total reflux episodes of acid \>55 or weakly acid \>26 for \>5 seconds at 5 cm above LES)
5. Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

Exclusion criteria:

1. Presence of para-esophageal hernia or sliding hernia \> 3 centimeters,
2. Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,
3. History of bariatric surgery wherein the stomach fundus has been extirpated,
4. Female patients who are pregnant or nursing,
5. Known sensitivity or allergies to silicone materials,
6. Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry study procedure (as outlined in the IFU);
7. Patients that are unable to comply with the registry study requirements, (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the registry study according to the investigator's judgement).
A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia

The study was designed as a prospective, multicenter, randomized, open-label, parallel-controlled clinical trial. The study population was patients with vulvar leukoplakia, and compared the efficacy and safety of AI temperature-controlled radio frequency technology and electrical stimulation in the treatment of vulvar leukoplakia. According to the research purpose, the sample size was calculated and determined to be 120 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 60 cases in the radio frequency observation group and 60 cases in the electric stimulation control group.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;
2. 18 to 60 years old;
3. Agree to sign the informed consent;

Exclusion Criteria:

1. Patients with severe liver and kidney dysfunction;
2. Combined with HIV, syphilis infection, acute vaginitis, cervical cancer;
3. Patients with cardiovascular disease;
4. People with hematological diseases;
5. Patients with hypertension and diabetes;
6. People with mental illness;
7. Pregnant and lactating women.
Neural, Behavioral and Physiological Correlates of Feeding in Humans

The overarching goal of this project is to understand how nicotine addiction interacts with feeding behaviors and brain representation of food reward. The current proposal is part of a larger effort to begin a program of research to elucidate similarities and differences in perception of, and behavioral and neural response to, food and cigarette aromas as a function of 1) smoking status (smokers, ex-smokers who do gain weight, ex-smokers who do not gain weight, non-smokers), 2) internal state (hungry, full), and 3) cigarette deprivation (acute, chronic). A general hypothesis is that there are overlapping neural mechanisms governing food reward and cigarette reward in smokers and that this overlap includes incentive salience encoding.

Weight gain frequently follows smoking cessation. Fear of weight gain is cited as a key reason not to quit and actual weight gain is a primary reason for relapse, especially among women. Although the causes of weight gain following smoking cessation are complex, increased caloric intake is recognized as one of the primary sources. One explanation for increased caloric intake is that, there are common neural mechanisms for food and cigarette reward and hence food reward can substitute for cigarette reward and vice versa. An alternative explanation for weight gain following smoking cessation is that there is an overall decrease in brain reward function during nicotine withdrawal, which leads to a decrease in the reward value of food and consequent increase in intake to maintain the total amount of reward obtained by food. The success of the proposed studies relies upon our ability to deliver odorants in the fMRI scanner and to measure neural activation in regions such as the amygdala, which are susceptible to inhomogeneity artifacts.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* between the ages of 18-45
* fMRI safe

Exclusion Criteria:

* outside of the above age range
* not able to have an fMRI (non-removable metal, pacemaker, etc)
* medical diagnosis related to neurological problems, anxiety, psychiatric conditions
* Did not refrain from smoking for the described time in the smoking group, or showed a CO2 level consistent with a smoker in the non-smoking group
A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.

This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-positive status.
* Screening viral load \>= 10,000 copies/mm3 14 days prior to entry.
* CD4+ cell counts \>= 200 cells/mm3 14 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Clinical diagnosis of AIDS (CDC 1993 Classification C).

Concurrent Medication:

Excluded:

Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.

Patients with the following prior conditions are excluded:

Clinically relevant hepatitis in the previous 6 months.

Prior Medication:

Excluded:

* Greater than 4 weeks of any nucleoside antiretroviral therapy.
* Previous therapy with an HIV protease inhibitor.
* Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
* Immunomodulating agents within 3 months prior to entry.

Prior Treatment:

Excluded:

Radiotherapy within 4 weeks prior to entry.

Risk Behavior:

Excluded:

Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.
Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder

This study will compare the short- and long-term effectiveness of two common therapies in improving serotonin reuptake inhibitor treatment in people with obsessive-compulsive disorder.

Obsessive-compulsive disorder (OCD) is a common psychiatric illness. People with OCD experience unwelcome thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. Impairment due to OCD symptoms ranges from mild to severe, and sometimes can be disabling. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Cognitive-behavioral therapy (CBT), a talking therapy that focuses on altering a person's thoughts and behaviors, and the medication risperidone have both been commonly used for augmenting SRI treatment for OCD. This study will compare the short- and long-term effectiveness of exposure and ritual prevention (EX/RP), a type of CBT, and risperidone in augmenting SRI treatment in people with OCD.

Participants in this double-blind study will be randomly assigned to receive EX/RP, risperidone, or placebo in conjunction with their regular SRI medication. All participants will remain on their regular SRI at a stable dose. During the first 2 months of the study, participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response. Participants assigned to risperidone or placebo will meet with a psychiatrist once every 1 to 2 weeks. At the end of 8 weeks, all participants' OCD symptom severity will be assessed. During this time, participants who have responded to treatment will continue receiving the same treatment for an additional 24 weeks. Participants assigned to EX/RP will meet with a therapist no more than 15 times total, and participants receiving risperidone or placebo will meet with a psychiatrist once every 4 weeks. Outcomes will be reassessed at study completion.

Ortho McNeil Janssen Scientific Affairs, LLC are providing medication and placebos for this study.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00045903

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of OCD
* Currently on a stable and adequate dose of an SRI
* Sufficient severity of symptoms to warrant additional augmentation treatment

Exclusion Criteria:

* Medical or psychiatric conditions that would make participation in the study unsafe
* Currently receiving psychotherapy elsewhere at the time of study entry
* Previously (within 12 weeks prior to study entry) attended 8 or more sessions of EX/RP within a 2-month period or received at least 4 weeks of antipsychotic augmentation while on an adequate SRI dose
* Currently being treated with an SRI for the first time and has not yet responded, but has not tried another SRI
Evaluating Pediatric Ivermectin in Children Under 15 kg (EPIC-15)

The EPIC-15 trial will evaluate the safety, pharmacokinetics, acceptability, and efficacy of pediatric ivermectin (CHILD-IVITAB) in scabies infected children weighing 5 to less than 15 kg. This trial will support future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15 kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of pediatric ivermectin therapy


Eligibility Criteria:
Inclusion Criteria:

* Male or female child weighing 5 to \<15 kilograms
* ≥3 months old
* Scabies infestation
* Available to attend all study visits
* Parents/guardians/carers able to provide written informed consent

Exclusion Criteria:

The participant may not enter the trial if ANY of the following apply:

* A history of renal or hepatic impairment.
* Any other significant disease or disorder (e.g. moderate or severe malnutrition) which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participants who are participating or have participated in another research trial involving an investigational product in the past 12 weeks.
* Children with Crusted/Norwegian scabies or severe secondary bacterial infections (e.g. sepsis)
* Children who have taken ivermectin within the last month
* Children with known allergies to ivermectin or excipients
* Loa loa infection risk, assessed based on travel history to endemic areas
* Use of prescription (especially CYP3A4 inhibitors or inducers) or non-prescription drugs (except paracetamol at doses of up to 90 milligrams/kg/day), including vitamins (especially vitamin C), herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise participants safety; the investigator will take advice from the manufacturer representative as necessary.
* The investigator, health care provider or study staff feel that the participant is not suitable for study participation due to chronic illness, suspected underlying illness, or concerns that the participant will not adhere to follow-up schedule.
* Being born prematurely.
* Previously enrolled into this study
Investigation the Effect of the Social-Communication Area Developmental Screening Test for Infants and Young Children Training Program Applied in Addition to the DIR/Floortime™ Therapy Program in Children with Developmental Risk

The term "developmental risk" is used as a general term for developmental delays observed in infancy and early childhood. Developmental delay refers to the delay in children reaching developmental milestones compared to their peers. The DIR/Floortime™ therapy program is an approach that uses play as a therapeutic tool, emphasising the importance of interaction involving affect and excitement in a child's development. DIR/Floortime™ therapy program aims to support the child's development with a family-centred perspective by evaluating the child and the family together. DIR/Floortime™ therapy program is known to contribute to the functional and emotional development of children and the development of parenting skills of caregivers. The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) is a parent-reported developmental screening test that aims to identify 'delays' in the social communication area skills of infants and children. The SCASI training program is a training program for children and parents developed on the basis of this screening test, which includes targeted activities to support the development process according to the child's developmental level. To the best of our knowledge, there is no study investigating the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. The aim of the study is to examine the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. A total of 34 children with developmental risk between the ages of 1 and 3 will included in the study. Participants will randomly divided into two groups: control group (n=17) in which the DIR/Floortime™ therapy program will be applied and intervention group (n=17) in which the SCASI training program will be applied in addition to the DIR/Floortime™ therapy program. The DIR/Floortime™ therapy program will be applied by the therapist in the clinic for 50 minutes, 2 days a week for 12 weeks, and the SCASI training program will be applied by the parents at home, 2 days a week, for an average of 30 minutes a day, for 12 weeks. Demographic and clinic informations, SCASI test, Age and Stages Questionnarie (ASQ), Age and Stages Questionnaires: Social-Emotional (ASQ-SE) and Brief Infant and Toddler Social Emotional Assessment (BITSEA) will be used as outcome measures in the study.


Eligibility Criteria:
Inclusion Criteria:

* The child is between 1-3 years old
* The language of the parents and the child is Turkish
* Assessment of SİATT pre-test result as "developmental risk"
* Parents' willingness to participate in the study

Exclusion Criteria:

* Any cognitive impairment in the parents that may interfere with communication
* Illiteracy of parents
* The child has orthopedic, neurological disability(s) other than developmental risk
Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis

The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of tinea cruris, tinea pedis, or tinea corporis. Additional criteria listed in protocol

Exclusion Criteria:

* Pregnancy and allergies. Additional criteria listed in protocol
E-cigarettes and Blood Vessel Function

Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on endothelial function and markers of oxidative stress.

Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and undergo a measure of endothelial function called brachial artery flow mediated dilatation (FMD). Additionally, oxidative stress will be measured pre and post exposure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Cardiac disease
* Respiratory disease
* Diabetes mellitus
Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.


Eligibility Criteria:
Inclusion Criteria:

* Transitional cell carcinoma
* Histologically-proven
* Locally advanced unresectable or metastatic
* With at least one measurable target
* Informed consent signed

Exclusion Criteria:

* Previous chemotherapy
* Previous radiotherapy
* Performance status \>=2
* Peripheral neuropathy \>=1
Spanish Registry on Spontaneous Coronary Artery Dissection

Multicenter observational prospective registry, Spanish nationwide-based, of consecutive patients diagnosed with Spontaneous Coronary Artery Dissection (SCAD)

Multicenter prospective registry on patients with diagnosis of Spontaneous Coronary Artery Dissection (SCAD). Spanish nationwide based, the aims of the current registry are:

1. To analyze predisposing factors, potential triggers and associated pathologies of patients presenting with SCAD.
2. To study the clinical and angiographic presentation of these patients.
3. To analyze the value of intracoronary diagnostic techniques (OCT, IVUS) and non-invasive imaging techniques in the diagnosis of this pathology.
4. To better understand the in-hospital clinical evolution and the response to medical treatment or revascularization in these challenging patients, taking into account the angiographic or intravascular imaging morphological characteristics of SCAD and the treatment applied.
5. To analyze its long-term clinical evolution (adverse cardiovascular events, including recurrence of SCAD).
6. To identify those factors directly related to prognostic and risk of recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Those consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that, after careful information, accepted to sign the informed consent form.

Exclusion Criteria:

* Those patients unable to provide informed consent.