cyrilzakka/clinical-trials huggingface dataset:
Qsymia as an Adjunct to Surgical Therapy in the Superobese

This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese individuals planning to undergo weight loss surgery. Individuals taking the medication before and after surgery will be compared to historical controls who had surgery without taking the medication.

While there is obvious focus on the obesity epidemic that affects approximately one-third of the U.S. population, one subgroup within the epidemic remains on the fringe of scientific study and effective treatment options. The super obese patient, in this instance defined as those with a BMI ≥ 50 kg/m2, presents a difficult treatment challenge in managing this level of obesity. While bariatric surgery, including Roux-en-Y gastric bypass and biliopancreatic diversion with duodenal switch, have been shown to be effective in severe obesity (BMI ≥ 40 kg/m2), the risks involved with surgical intervention in the super obese patient are high.

Qsymia provides a potential opportunity to develop an effective treatment plan that would be an adjunct to surgical intervention in the super obese patient. Use of Qsymia in addition to a low-calorie dietary prescription pre-operatively would effectively decrease weight prior to surgical intervention, lowering surgical risk to some extent. Additionally, if continued post-operatively, Qsymia as an adjunct to the post-surgical dietary plan would potentially extend the weight loss horizon so that the probability of the typical weight loss plateau at 12-18 months is decreased.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 50 kg/m2
* Determined to be a good candidate for surgery based on medical and psychological exam.
* Willing to participate in a 3-6 month medically supervised weight loss plan prior to surgery.
* Planning to remain in the reasonable vicinity of the Wake Forest Baptist Health - Weight Management Center for the duration of the study.

Exclusion Criteria:

* History of prior weight loss surgery (removal/conversion from band to sleeve will not be excluded)
* Pregnant (women of childbearing potential will complete a pregnancy test (blood draw) to make sure they are not pregnant at the time that they initiate the medication). Ongoing monitoring of pregnancy status is the responsibility of the patient and they are instructed as such in the consent form.
* Ongoing use of weight loss medication
* Contraindications to use of Qsymia, including pregnancy, history of glaucoma, unstable cardiac disease (unstable angina, recent heart attack or stroke (in the past 6 months), uncontrolled arrhythmia), hyperthyroidism, taking monoamine oxidase inhibitors (MAOIs) or allergy to either topiramate or sympathomimetic amines like phentermine.
Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure

This study will evaluate the applications of ganglionar electrical stimulation in patients with Chagas Disease and Ischemic Heart Failure patients.

A Crossover Randomized Controlled Study will be developed with 3 groups: Healthy Older, Ischemic Heart Failure and Chagas Disease. This individuals will be randomized in two groups: TENS and placebo (same stimulus without electrical output) with 48 hrs between the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic and Chagas disease previously diagnosticated
* Age above 40 years old

Exclusion Criteria:

* No vascular disease
* No recent surgery
* No recent infections
A Study of the Efficacy and Safety of ICA-17043 (With or Without Hydroxyurea) in Patients With Sickle Cell Anemia.

ICA-17043 is being developed for the chronic treatment of patients with sickle cell disease (SCD) in both adults and children. ICA-17043 is a potent and specific inhibitor of a channel in human red blood cells (RBCs) that blocks RBC dehydration. ICA-17043 is expected to inhibit RBC dehydration and thus should prevent or delay the sickling process. By reducing sickled cells, an improvement in anemia, a reduction in painful crises, and ultimately, less end-organ disease is anticipated.


Eligibility Criteria:
Inclusion Criteria:

* Homozygous (HbSS) Sickle Cell Anemia
* Otherwise healthy (based on medical history, physical examination, 12-lead ECG, and clinical laboratory tests)
* Patients may be receiving hydroxyurea, but must have been dose stabilized for at least 3 months
* Patient has a history of at least one acute vaso-occlusive event requiring hospitalization

Exclusion Criteria:

* Patient participating in a chronic transfusion program
* Patient having a total hemoglobin of \< 4.0 g/dL or \> 10.0 g/dL
* Patient having a HbA \> 10%
* Patient considering undergoing an elective surgery
* Patient taking prohibited medications such as Epoetin, Warfarin, etc.
* Patient who has had previous gastrointestinal surgery, except cholecystectomy or appendectomy
* Patient with significant active cardiovascular, neurologic, endocrine, hepatic, or renal disorders unrelated to sickle cell anemia
A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU

Inspiratory muscle training (IMT) is an intervention used with success in the outpatient setting within the COPD population. Use of IMT is also theoretically possible during mechanical ventilation. This study will will assess the feasibility and safety of the study of IMT in the patient population.


Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients.
* Must have passed spontaneuos brething trial screening but failed the trial itself.
* Potential subject must be able to perform atleast 5 minutes of spontaneous breathing trial.

Exclusion Criteria:

* Known neuromuscular disease
* Unstable cardiac ischemia
* Tracheostomized patients
MMF After Pediatric Liver Transplantation

The use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver transplantation is one of the main causes of chronic kidney disease in these patients in the long term.

The study objective is the evaluation of safety of a modification in immunosuppression from a dual-immunosuppression (CSA or FK plus steroids) to a triple immunosuppression (MMF plus CSA (reduced dosage) plus steroids.


Eligibility Criteria:
Inclusion Criteria:

* patients after pediatric liver transplantation
* no acute rejections for the last half year

Exclusion Criteria:

* concomitant malign disease (e.g. ptld)
* neutropenia (granulocytes \<1000/µl)
* systemic infection
* thrombopenia (\<80/nl)
Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival

The purpose of this prospective cohort study is to determine factors involved in survival in new COPD patients treated by long-term oxygen therapy.

Background: long-term oxygen therapy is indicated in patients with severe COPD. No studies have been performed in the past 20-25 years to examine the results of early clinical trials. Further studies are necessary to understand the utility of oxygen therapy in severe COPD.

long-term oxygen therapy prolongs life in patients with severe COPD and severe resting hypoxemia. The objective of this study is to measure the survival in relation to the level of initial resting hypoxemia, serious co-morbidities, and nutritional status in COPD patients treated by long-term oxygen therapy. After enrollment at the beginning of oxygen therapy, following data will be collected during 3 years. Lung function, blood gas analysis, exercise capacity measured by the 6-Min Walk Distance test (6-MWD), dyspnea scale, BODE index, quality of life, indirect and direct costs will be analyzed every year.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients on necessity of long-term oxygen therapy
* Patients treated by LTOT, with or without clinically fulfilled criteria for LTOT, with PaO2\<55mmHg or less at rest or during sleeping or less during exercise, if supplemental oxygen is demonstrated to improve the exercise-associated hypoxia. Patients with PaO2 56-59mmHg if they also have dependent edema, pulmonary hypertension or hematocrit higher than 56%
* Patient clinically stable
* Patient with oxygen device of ANTADIR network
* Oral and written consent

Exclusion Criteria:

* Patient with obstructive sleep apnea or overlap syndrome
* Patient with non invasive ventilation
* Patient with evolutive cancer.
* Inability to complete questionnaires
* Inability to attend outpatient clinic
Exercise Preconditioning in Ovarian Cancer

The purpose of this study is to determine if exercise preconditioning can mitigate the off target effects of chemotherapy treatment on measures of cardiovascular function, peripheral neuropathy, and quality of life.

While survivorship for those diagnosed with epithelial ovarian cancer has continued to improve, the significant off target effects of adjuvant and neoadjuvant chemotherapy have become more prominent. These off-target effects include increased risk of cardiovascular disease, neuropathy, and decreased quality of life. Exercise initiated prior to chemotherapy induction and continued through treatment has promise in terms of preserving VO2peak and potentially mitigating the negative cardiovascular and neuropathic effects of chemotherapy. The goal of this study is to examine the effects of initiating exercise prior to any oncologic therapy and sustaining this exercise paradigm in newly diagnosed women with ovarian cancer who are undergoing initial surgery and chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over
* Presumed diagnosis of ovarian cancer and a planned chemotherapy regimen of a taxane and carboplatin with or without VEGF inhibition
* Physician clearance for exercise training

Exclusion Criteria:

* Any patient unable/unwilling to cooperate with all study protocols
* Cancer recurrence
* Previous treatment with chemotherapy in the last 5-years
* Medical/orthopedic co-morbidities that preclude exercise training
* Significant heart, liver, kidney, blood, or respiratory disease precluding exercise participation
* Peripheral vascular disease
* Acute infectious disease or history of chronic infections
An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer

A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of high risk relapsed/ refractory osteosarcoma
* Aged \<= 40 years at the beginning of treatment
* at least one completed cycle of HD IFO through elastomer (14g/mq) in 14 days
* disease evaluation according to RECIST criteria v.1.1

Exclusion Criteria:

* none
A Global Study of the PETAL Consortium

The goal of this observational study is to correlate molecular alterations with outcomes including overall survival (OS), progression-free survival (PFS), response rates for patients with a new diagnosis, primary refractory or relapse, of mature T-cell and NK-cell neoplasms (TNKL). We hypothesize that machine learning can be leveraged to uncover distinct genetic vulnerabilities that underlie treatment response and resistance for patients with TNKL, thus moving towards personalized treatment solutions.

This study is a prospective, longitudinal observational study of patients with newly diagnosed or relapsed/refractory T-cell and NK-cell neoplasms, conducted across multiple participating institutions globally. Patients will be enrolled during their initial visit as new patients and will be followed for up to four years through the course of their clinical management. Data for routine demographics, baseline clinical features, including pathology, molecular information related to the tumor, radiology, treatment characteristics and quality of life (QoL) associated with their lymphoma care will be collected over the course of 4 years by clinical research teams at every participating institution. The de-identified data will be securely shared through a password protected REDCap with other participating institutions under data usage agreements of the consortium. Next generation sequencing (NGS) including but not limited to whole exome sequencing and bulk RNA-sequencing will be performed on archived lymphoma specimens, mononuclear cells, cfDNA and saliva (when feasible) for a comprehensive molecular characterization of the tumor. Molecular data will be analyzed in correlation with patient outcomes. Advanced deep learning algorithms will be applied to predict responses and survival across lymphoma subtypes, heterogeneous clinical scenarios and various potential therapeutic approaches that the patient has not been exposed to.

Eligibility Criteria:
Inclusion Criteria:

* Untreated, relapsed, or refractory histologically confirmed mature T-cell or NK-cell neoplasm.
* All subtypes of PTCL are eligible except for T-cell large granular lymphocytic leukemia, cutaneous T-cell lymphoma such as but not limited to mycosis fungoides and transformation, Sézary syndrome, and primary cutaneous CD30+ disorders.

Exclusion Criteria:

* Precursor T/NK neoplasms, T-cell large granular lymphocytic leukemia, cutaneous T-cell lymphoma such as but not limited to mycosis fungoides and transformation, Sézary syndrome, and primary cutaneous CD30+ disorders.
* Adults who are unable to consent, individuals who are not yet adults such as infants, children and teenagers, pregnant women, and prisoners.
Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage

Clarify the therapeutic differences between robot assisted endoscopic clearance and traditional puncture and external drainage, and establish a new minimally invasive surgical diagnosis and treatment strategy for intraventricular hemorrhage


Eligibility Criteria:
Inclusion Criteria:

* Age range from 18 to 80 years old;

  * The time from onset to first CT confirmation of intraventricular hemorrhage is less than 24 hours;

    * Before enrollment, CT confirmed that the intraventricular hemorrhage score (modified Graeb score) was ≥ 8 points, and the total score of bilateral lateral ventricles was ≥ 5 points;

      * If there is concurrent cerebral hemorrhage but the hematoma volume is less than 30ml;

        ⑤ First CT to surgery time\<72 hours;

        ⑥ GCS ≤ 14.

Exclusion Criteria:

* ① Suspected (unless excluded by angiography or CTA/MRA/MRI) or untreated rupture of cerebral aneurysm, Moyamoya disease, intracranial AVM rupture, or tumor;

  * Patients with a GCS score of 3 and/or fixed dilated pupils and/or no spontaneous breathing;

    * Patients with pre-existing neurological disorders that affect neurological function assessment prior to onset;

      * Coagulation dysfunction;

        * Patients who require long-term anticoagulant treatment;

          ⑥ Use dabigatran, apixaban, and/or rivaroxaban (or drugs of the same class) before symptoms appear; ⑦ Platelet count\<100 × 109/L, INR\>1.4;

          ⑧ Pregnancy (positive serum or urine pregnancy test);

          ⑨ Subtentorial hemorrhage or brainstem hemorrhage;

          ⑩ Patients who have previously participated in other interventional clinical studies and participated in observational, natural history, and/or epidemiological studies that do not involve intervention are eligible;

          ⑪ Subjects who are expected to not survive until the 180th day of visit; No written informed consent was given by the subjects or legal representatives.
Effect of Clinical Crown Lengthening Surgery and Botulinum Toxin A Injection in Gummy Smile Treatment

Background: The demand for beauty is increasing in society as everyone is looking for cosmetic improvement, including gummy smile correction.

Object: This study aims to evaluate the efficacy of a combination of a clinical tooth crowns lengthening surgery following by a BTX-A injection in gummy smile treatment upon based on clinical assessment and photography

Method: An uncontrolled longitudinal study was implemented at the Faculty of Odonto-Stomatology (FOS) of the University of Medicine and Pharmacy at Ho Chi Minh City (UMPH), Viet Nam, from August 2020 to May 2021. Twenty patients (19 females and one male) at a mean age of 24 years old who came for gummy smile chief complaint were included in the study. Subjects were operated to lengthen the clinical crown following an additional botulinum toxin A injection two months post-surgery. All the participants answered the smile esthetic satisfactory questions and were photographed at the time before treatment (T0), two months after clinical crown lengthening surgery (T1), two weeks (T2), and two months (T3) follow-up visits after BTX-A injection. The gingival exposure (GE) and clinical crown length (CCL) were measured at each time point for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Gummy smile because of 2 combined etiologies:

  * Short clinical crown of teeth due to the altered passive tooth eruption
  * Hyperactivity of upper lip muscles (lip mobility level \> 8mm)

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Gummy smiles due to:

  * Maxillary bone overgrowth (maxillary hypertrophy)
  * Vertical maxillary excess
  * Neuromuscular disorder
  * Gingival hyperplasia due to medicine, supplements, or neuromuscular transmission inhibiting agents
* Systematic diseases that can affect the result of surgical treatment (such as diabetes, heart disease taking blood anticoagulant medicament, blood diseases, immunodeficiency disease etc.)
* Allergy to BTX-A or albumin
* History of taking BTX-A injection in the head-neck area formerly
* Patient with any contraindication of surgery
Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia

The aims of this study are:

1. To determine the correlation between pulmonary functions and physical fitness in children with β-thalassemia.
2. To differentiate between different types of B-thalassemia in both pulmonary functions and physical fitness

Cohort study: cross-sectional design

A) Subjects:

Sample size estimation will be carried out to determine the recruited number of children selected randomly. Each participant's caregiver will sign a consent form authorizing the participation of their children in this study.

They will be selected based on the following:

Inclusion criteria:

* age range from 6 to 12 years
* children with β-thalassemia major and intermediate of both sex and control healthy children of both sex
* They can follow instruction

Exclusive criteria:

Children will be excluded from the study if they have:

* Defined Cardiovascular or respiratory disorders.
* Renal failure
* Visual or hearing impairment, Mentally retarded children
* Myocardial infarction within the last month
* Unstable angina, Recent thoraco-abdominal surgery
* Thoracic or abdominal aneurysm or Current pneumothorax

II) Materials

1. For evaluation of pulmonary functions The measurements that are made include forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and the ratio of the two volumes (FEV1/FVC).
2. For evaluation of physical fitness Aerobic capacity and endurance By 6-Minute Walk Test , 3 minutes step test and Energy expenditure BMI Balance Pediatric balance scale

Eligibility Criteria:
Inclusion Criteria:

* • age range from 6 to 12 years

  * children with β-thalassemia major and intermediate of both sex and control healthy children of both sex
  * They can follow instruction

Exclusion Criteria:

* • Defined Cardiovascular or respiratory disorders.

  * Renal failure
  * Visual or hearing impairment, Mentally retarded children
  * Myocardial infarction within the last month
  * Unstable angina, Recent thoraco-abdominal surgery
  * Thoracic or abdominal aneurysm or Current pneumothorax
Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)

This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Demonstrates good general health
* Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative
* Low risk of acquiring HIV infection
* ALT lab value within normal range

Exclusion Criteria:

* Previously received an investigational HIV vaccine
* Has a known or suspected impairment of immunologic function
* Has a clinically significant chronic medical condition that is considered progressive
* Has a major psychiatric illness
* Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer
* Weighs less than 105 lbs.
* Has a recent (within two years) history of chronic alcohol abuse
* Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
* Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study
* Male subject is planning to impregnate or provide sperm donation during the study
Sleep-disordered Breathing in Postmenopausal Women

The purpose of this study is to investigate the effectiveness of CPAP treatment to co-morbidities of sleep apnea by looking the change of the consumption of medication of the co-morbidities before and after starting the CPAP treatment.

Sleep-disordered breathing (SDB) is frequently linked with cardiovascular diseases including stroke and type 2 diabetes, which increase the indirect costs of sleep apnea. Also non-cardiovascular co-morbidities are possible but seldom studied. CPAP treatment reverses the increased healthcare utilization seen before the sleep apnea diagnosis.

Previous studies addressing the cardiovascular co-morbidities in SDB have focused on obstructive sleep apnea and in male populations, but not on partial upper airway obstruction. Partial upper airway obstruction is common in both genders but especially in women. According to investigators' clinical experience, women with partial upper airway obstruction are especially likely to have severe symptoms from their SDB. There are scarce data on cardiovascular co-morbidities associated with partial upper airway obstruction and the female gender.

To study the prevalence of co-morbidities adding to the burden of SDB (periodic obstructive breathing and partial upper airway obstruction), investigators applied a conservative but robust strategy using the governmental database of medication reimbursed by the public health insurance system. Investigators analyzed both the cardiovascular and non-cardiovascular co-morbidities in our clinical population of SDB, separately in patients with periodic obstructive breathing or with partial upper airway obstruction during sleep.Investigators found that concomitant diseases ware common in SDB. Asthma and/or COPD were surprisingly frequent, and also chronic hypertension had an increased prevalence. In addition, males had diabetes mellitus and females hypothyroidism more than general population. The results emphasize the importance of diagnosis and treatment of the co-morbidities such as asthma, COPD, hypertension, diabetes and thyroid insufficiency regardless if the patient has partial upper airway obstruction or obstructive sleep apnea.

Now, investigators hypothesize that CPAP treatment reduces the consumption of medication of the co-morbidities of sleep apnea. Therefore, a retrospective analyze of 5 year before and 5 year after starting the CPAP treatment the medication consumption of the same population previously used will be conducted. To do this, the governmental database of medication reimbursed by the public health insurance system will be used.

Eligibility Criteria:
Inclusion Criteria:

* patient with sleep apnea
* CPAP treatment started and continued

Exclusion Criteria:

* no CPAP treatment started