cyrilzakka/clinical-trials huggingface dataset:
Effect of AD128 to Treat Obstructive Sleep Apnea

This study evaluates the combination of two drugs (AD128), to treat obstructive sleep apnea (OSA) severity. After a baseline evaluation and during 7 days, half of the participants will randomly receive this drug combination (AD128) and the other will receive a placebo, i.e. a drug without pharmaceutical effect. Neither the participants, nor the investigators will know in which arm participants are until the end of the study. After one week of trial, an evaluation will be perform and will be follow by one week without any treatment. During the third and last week of trial, there will be a crossover of the groups, i.e. the participants of the first group who took the two drugs (AD128) during the first week will take a placebo and those who took the placebo will take the drugs combination.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years and ≤ 65 years)
* New or previous diagnosis of OSA with an AHI \> 15/h on a polygraphic or polysomnographic recording (Participants already treated with continuous positive airway pressure (CPAP) or mandibular advancement device can be included but a 7-days wash-out period is required before the beginning of the protocol and CPAP usage will not be possible during the whole protocol duration),
* Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

* History of seizures,
* History of glaucoma,
* History of benign prostatic hyperplasia, organic miction disorder or urinary retention,
* Gastrointestinal disease (e.g. stenosis, occlusion, ulcerative colitis, toxic megacolon, hiatal hernia...)
* Cardiac arrhythmia,
* History of bipolar disorder,
* Use of respiratory stimulants or depressants,
* Use of Hypnotics,
* Use of Central nervous system stimulants,
* Use of Monoamine oxidase inhibitors (MAOIs) antidepressant,
* Major depressive disorder,
* Central sleep apnea representing more than 10% of all respiratory events
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* Pregnant or breast feeding female participants or participants who intend to become pregnant during the study (However, there is no contraindication to contraception),
* Other clinically significant concomitant disease states (renal failure, hepatic dysfunction, severe cardiovascular or respiratory disease, myasthenia gravis, cerebral sclerosis),
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Use or morphinic and derivatives which may influence sleep,
* Refusal to be informed in case of incidental findings.
Personalized Therapy Study - Attain Stability Quad Post-Approval Study

The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).

The Attain Stability Quad (ASQ) PAS is a multi-center, single arm, prospective observational study. However, in the US, retrospective enrollments from participants in the IDE study (IDE #G170020) are allowed.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with a Model 4798 lead and a Medtronic CRT device
* Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease

A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.

This study will be a proof of concept, Phase 2a study in patients with early Alzheimer's disease (clinical diagnosis of Alzheimer's disease Stage 3 or 4 based on the National Institute on Aging Alzheimer's Association Research Framework criteria) to evaluate the Pharmacodynamic, cognitive effects, Pharmacokinetic, and safety and tolerability of obicetrapib therapy.

Eligibility Criteria:
Inclusion Criteria:

* men \& women 50-75 years
* post-menopausal or women not of child-bearing potential
* diagnosis of Alzheimer's disease based on National Institute for Aging:
* Biomarker classification A+T+N+ or A+T+N-
* Clinical Stage 3 or 4 with Clinical Dementia Rating score \>/= 0.5 \& \</= 1; mini-mental state examination (MMSE) score \>/=20
* Have an APOE genotype of E4/E4 or E3/E4
* not on or on stabilized AD medication
* Patient \& study partner willing to sign consent

Exclusion Criteria:

* Other than AD, disorder that may impair cognition
* Contra-indication for MRI
* History of neurological, psychiatric or mental conditions;

  * history stroke
  * MI
  * Type 1 diabetes \& Type 2 with HbA1c\>8%
  * BP \> 150/90 mmHg
  * renal or hepatic impaired
  * hyperaldosteronism
  * cancer
  * depression
  * laboratory abnormalities
  * not able to undergo lumbar puncture
  * taking certain medications including lipid altering
Effect of Spontaneous Breathing on Atelectasis During Induction of General Anesthesia in Patients in Infants

spontaneous breathing on occurrence of atelectsis in infants

Keeping the spontaneous breathing during the anesthesia for 5 minutes and occurrence of atelectasis

Eligibility Criteria:
Inclusion Criteria:

* general anesthesia

Exclusion Criteria:

* heart or lung problems
* prematurity
Memantine in Patients With Chronic Glaucoma

Randomized double-masked clinical trial of memantine in patients with glaucoma


Eligibility Criteria:
Inclusion Criteria:

* glaucoma damage on examination of visual field and optic disc
* good visual acuity (with glasses if needed)
Breast Cancer Resiliency Through Exercise Program (B-REP)

The study will use a cross-sectional study design with a follow-up 2-arm randomized controlled trial with that has assessments at baseline, post-intervention (i.e., Week 12), and 3-months post-intervention (i.e., Week 24). The 2 arms are the 12-week intervention and a health education control among 60 Black breast cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

Women will be eligible if they meet the following criteria:

* self-identify as Black or African American or Afro-Latina/e;
* are ≥18 years old;
* have a confirmed diagnosis of breast cancer, Stage I to IIIA;
* have completed primary active treatment (i.e., surgery, chemotherapy, and radiation) within 5 years prior to study start where concomitant hormonal therapy is acceptable;
* are not meeting current cancer-specific resistance exercise guidelines of ≥ 2 times per week; and
* are able to speak and understand English.

Exclusion Criteria:

* metastatic disease;
* medical reason that precludes them from increasing current exercise levels;
* planned elective surgery during study period;
* pregnant or plans to become pregnant during the study period;
* plans to move out of United States during the study period; (the rationale for this exclusion is that it will be difficult to conduct the in-person assessments if a participant leaves the United States);
* current enrollment in another exercise trial; and/or
* inability to pass exercise pre-screening or receive physician consent to increase current physical activity levels.
RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil

The perinatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. This study tests the likelihood that the joint administration of antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia.

The maternal, perinatal and neonatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. In Sao Paulo, 22 percent of maternal deaths are attributable to hypertensive complications of pregnancy, which ranks as the number one cause of maternal death. Recent advances in the understanding of the pathophysiology of preeclampsia suggest the possibility of antioxidant therapy for the prevention of preeclampsia. The primary hypothesis is that the joint administration of the antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia. Secondary outcomes include severity of preeclampsia; incidence of gestational hypertension; incidence of premature rupture of the membranes; incidence of preterm birth; incidence of low birth weight infants; biomarker level correlation with preeclampsia.

Study sites are high-risk obstetrical clinics in the Brazilian cities of Recife, Botucatu, Campinas, and Porto Alegre. The sample size was based on an estimated risk of preeclampsia/eclampsia of 21-25% in the control group. The study hypothesizes a 40% absolute reduction of risk of preeclampsia; early treatment withdrawal of 3%; withdrawal of consent or loss to follow-up of 10%; calculated at a 0.05 significance level with 80% power. Seven hundred thirty-four obstetric patients with chronic hypertension or preeclampsia in the prior pregnancy presenting for care between 12 weeks and 19 weeks', 6 days gestation will be randomized to a double-blinded placebo controlled trial to receive a daily dose of either vitamin E (400 International Units) and vitamin C (1000 mg) or placebo from the time of enrollment to delivery. The use of MEMS caps enables researchers to accurately track compliance.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 12 weeks and 19 weeks, 6 days, inclusive
* Chronic hypertension
* History of preeclampsia/eclampsia
* Attendance at a participating hospital (Recife, Botucatu, Campinas and Porto Alegre, Brazil)

Exclusion Criteria:

* Planned delivery elsewhere.
* Multifetal gestation.
* Allergy to vitamin C or vitamin E.
* Requirement for aspirin or anticoagulant medication.
* Proteinuria ≥ 2+ on dipstick urine test; or proteinuria = 1+ on dipstick and ≥ 300 mg/24 hours.
* Pre-pregnancy diabetes mellitus.
* Known fetal anomaly incompatible with life.
* Prior participation in the study.
* Unwillingness to take the study medication.
Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis

Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis may be difficult and cyclosporine can induce some remission.

The investigators hypothesized that the combined use of live attenuated varicella vaccine as an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis can give positive responses.


Eligibility Criteria:
Inclusion Criteria:

* Severe psoriasis: At least 30% of body involved) according to the rule of nine.
* Resistance to conventional therapy (PUVA, methotrexate, retinoids):

(Maximum PASI 50% improvement while on treatment for a duration not less than 6 months).

* Immunologically competent individuals with
* Seropositive for the varicella antibodies

Exclusion Criteria:

* Any contraindication to live attenuated varicella vaccine
* Any contraindication to cyclosporine
A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer

This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
* HER2 positive tumor (primary tumor or metastasis
* ECOG Performance status 0, 1 or 2
* Life expectancy of at least 3 months

Exclusion Criteria:

* Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
* Patients with active (significant or uncontrolled) gastrointestinal bleeding
* Residual relevant toxicity resulting from previous chemotherapy
* Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)
Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers

Pertussis is a bacterial respiratory infection caused by Bordetella pertussis. Highly contagious, it is potentially serious and even fatal in infants under 6 months of age. The immunity acquired through vaccination is very limited in time, requiring regular booster shots. There is a passive protection of the newborn by the maternal-fetal transmission of maternal antibodies, but it is brief. The infant's first vaccination is given at 2 months of age and immunity is not acquired until the second injection at 4 months of age. The booster at 11 months of age is essential to prolong this immunity.

In order to protect infants under 6 months of age, France has recommended since 2004 the cocooning strategy, which consists of vaccinating people likely to be in close contact with the infant during this period. This vaccination is therefore proposed to adults who are planning to have children, to the entourage of pregnant women, and in the immediate post-partum period for the mother (and people who were not vaccinated during pregnancy). This strategy was put in place following the international recommendation of a forum of scientific experts, the Global Pertussis Initiative.

In France, vaccination against pertussis is not currently recommended during pregnancy. There is no contraindication to vaccination during pregnancy and it is recommended in many countries.

Influenza is a viral respiratory infection caused by Myxovirus influenzae, which is highly contagious.

In France, vaccination against influenza is recommended for pregnant women, regardless of the trimester of pregnancy. It is also recommended for the entourage of infants under 6 months of age with risk factors for severe influenza.

There are few recent data in the scientific literature regarding influenza and pertussis vaccination coverage among pregnant or postpartum women in France. In addition, the COVID19 pandemic has recently reopened the debate on vaccination of the general population and caregivers. Knowing the current status of vaccination coverage among pregnant women and caregivers, their knowledge and fears regarding vaccination could help improve the information provided by healthcare staff.


Eligibility Criteria:
Inclusion Criteria:

* Person having received complete information about the research and not opposed to the study.
* Hospitalization in the post-partum service and within the last 5 days of delivery.
* women. caregivers

Exclusion Criteria:

* Female under 18 years of age,
* Woman under legal protection,
* Delivery of a stillborn child,
* Premature delivery \< 35GA,
* Hospitalized newborn,
* Women who doesn't speak french.
NASH in Subjects With Different Classes of Obesity

It is an observational trial on 500 subjects. The purpose of this trial is to assess the prevalence of non-alcoholic steatohepatitis (NASH) in subjects with different classes of obesity.

Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common cause of chronic liver disease due to an increase in the prevalence of obesity. The development of NASH leads to an increase in morbidity and mortality. Since patients with obesity are at an increased risk of NASH, the aim of this trial is to assess the prevalence of NASH in this class of patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 19 and 69 years

Exclusion Criteria:

* Pregnancy
* Active cancer
* End stage renal failure
* End stage liver failure
* Being unable to understand and sign informed consent
Impact of Skeletal Muscle Quality and Loss on the Outcome of Liver Transplantation

CT imaging-based skeletal muscle assessment has been found to predict the outcomes of many diseases. Previous evidence revealed that pre-transplant muscle quality and post-transplant muscle loss were associated with transplant outcomes. However, there is no prospective study supporting the aforementioned conclusions. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant CT images as well as post-transplant CT images at specific time points. The objective is to further explore and clarify the correlation between skeletal muscle assessment and the prognosis of liver transplant patients. The goal is to provide guidance for peri-transplant health monitoring and disease intervention for liver transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing deceased donor liver transplantation (DDLT) for the first time

Exclusion Criteria:

* Pediatric transplants
* Presence of portal vein tumor thrombus according to imageing before transplantation
* Presence of macrovascular invasion according to imageing before transplantation
* Re-transplants
* Multi-organ transplants
* Patients who died within 30 days after transplantation
* Patients diagnosed with skeletal muscle diseases (e.g. muscle atrophy)
* Patients with serious medical conditions such as heart failure, persistent infection, and renal insufficiency.
Antibiotic Adherence Practices in Dermatologic Surgery

This multi-center prospective observational cohort study will examine the prevalence of non-adherence along with analyze the risk factors of non-adherence for patients presenting to dermatologic surgery. Patients prescribed antibiotics will be invited to participate in the study and appropriate follow up to inquire about antibiotic usage will be conducted. All data will be collected and stored in a secured REDCap database managed by the Penn Dermatologic Surgery Clinical Research Team.

This multi-center prospective observational cohort study will examine the prevalence of non-adherence and analyze the risk factors of non-adherence for patients presenting to dermatologic surgery. Patients prescribed antibiotics will be invited to participate in the study and appropriate follow up to inquire about antibiotic usage will be conducted. Inclusion criteria are 1) Patients with age greater than or equal to 18 who are capable of providing informed consent and 2) Patients who have been prescribed antibiotics following their visit with a dermatologic surgery department. We plan to examine patients who have presented to a dermatologic surgery clinic and were prescribed antibiotics from June 1, 2019 to June 1, 2021 at the University of Pennsylvania Health System and other Institutional Review Board (IRB) approved sites. After obtaining informed consent at their visit to enroll in the study, variables of interest will be collected from patients including name, date of birth (DOB), gender, visit date, contact information, antibiotic regimen, and 4 question survey assessing adherence. Follow up via patient's preferred method of contact will be conducted after the patient's intended antibiotic completion date and covariates for antibiotic regimens will be recorded including antibiotic type, number of doses, antibiotic duration, reason for non-adherence, pills remaining, and number of other medications. All data will be collected and stored in a secured REDCap database managed by the Penn Dermatologic Surgery Clinical Research Team.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than equal to 18
* All patients presenting to one of the dermatologic surgery settings approved by the IRB who are prescribed a post-operative antibiotic regimen

Exclusion Criteria:

* Patients who do not present to or are not prescribed post-operative antibiotics in a dermatologic surgery setting
The Effects Of Equal Breathing On Pain Pressure Thresholds

Recent research has found that there is moderate evidence for the use of breathing exercises for treating chronic, non-specific low back pain. Researchers have found that there were significant improvements in pain and quality of life in those suffering with low back pain who completed a breathing program intervention. Researchers also found that healthy individuals had higher pain thresholds and tolerance following deep and slow breathing exercises.

There are numerous formats of breathing interventions, some interventions that have been used with individuals with chronic, non-specific low back pain include: deep breathing, yoga breathing, resisted inspiration, and breathe holding. There is moderate evidence to suggest the use of these interventions for managing chronic low back pain Another common breathing format is Equal-Ratio Breathing. This format requires an individual to inhale and exhale with the same duration while gradually increasing the duration of both. This breathing format can be easier for patients to perform given the simplicity of the equal inhalation to exhalation ratio.

This research is being done because Equal-Ratio Breathing has yet to be studied in individuals with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18
* Chronic low back pain
* OHIP patient

Exclusion Criteria:

* Peripheral pain
* Peripheral neuropathy
* Chronic regional pain syndrome
* Alpha and Beta blocker medication use
* Patient does not wish to participate
* Completed or participated in a psychoeducational program at the clinic