cyrilzakka/clinical-trials huggingface dataset:
Bariatric Surgery and Guided Self-help for Binge Eating Disorder

To demonstrate the effectiveness of an easily administered intervention (guided self help) aimed at reducing binge eating in patients undergoing bariatric surgery.

The investigators hypothesize that patients who have guided self help pre-operatively will have reduced episodes of bingeing pre-operatively compared to those having treatment as usual (bariatric surgery), which will be maintained in the post-operative period, and will be associated with improved weight loss and psychological outcomes after surgery.

Binge eating disorder (BED) is distressing and common in patients who present for treatment for obesity. Despite this, it is often undiagnosed. Patients who have bariatric surgery have improvements in their eating patterns, including binge eating. However there is variability in the degree of weight loss and post-operative complications following bariatric surgery, associated with disordered eating.

Guided self help for BED (GSH) is a treatment which, like bariatric surgery, is effective in reducing the number of binge episodes in people who binge eat. It is not known whether GSH prior to surgery, in patients undergoing bariatric surgery has any additional benefit for reducing bingeing, or improving weight loss in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI \>28 kg/m2)
* Pursuing bariatric surgery

Exclusion Criteria:

* Any illnesses which make the patient unsuitable
* If the patient is taking any medication which makes them unsuitable
* If the patient is pregnant or breast feeding
* If the patient has donated blood in the last three months
* If the patient has a history of alcoholism or substance dependency within the last 5 years
* If the patient has a history of major haematological, renal, gastrointestinal, hepatic, respiratory, cardiovascular or psychiatric disease or other illness or use of any medications, including over the counter products, which, in the opinion of the investigators would either interfere with the study or potentially cause harm to the volunteer
* If the patient has any medical or psychological condition or social circumstances which would interfere with their ability to participate reliably in the trial
* If the patient is without access to a telephone
* If the patient is currently receiving or intends to receive treatment with an investigational drug within the next 2 months If the patient is currently receiving or intends to receive treatment for binge eating
* If the patient currently suffers with severe depression, as indicated by a Beck Depression Inventory Score greater than 28
Take HEED (Healthy Eating and Exercise Decisions)

This is a randomized intervention that examines the effect of culturally adapted weight loss program in African American (AA) females age 40-65. Evidence suggests that AA women are more successful with weight loss programs that are culturally tailored (Karanja, et al, 2002). Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from ATP-III and the CHANGE exercise program, which have shown success independently in previous clinical trials with AAs.

Project/study objective(s), This is a randomized intervention that examines the effect of culturally adapted weight loss program in African American (AA) females age 40-65. Evidence suggests that AA women are more successful with weight loss programs that are culturally tailored (Karanja, et al, 2002). Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from ATP-III and the CHANGE exercise program, which have shown success independently in previous clinical trials with AAs.

Methods, The 21 month program (6 months active intervention and 15 months maintenance) is provided by a Nurse matched with the study participants for race, age, and gender. Take HEED uses behavior change strategies (Prochaska et al 1992) which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support. The diet has been modified to include calorie reductions, increased fruit/ vegetable and calcium intake, incorporation of AA ethnic recipes. Exercise has been culturally adapted featuring line- dancing, brisk walking and includes socialization time for development of strong interpersonal bonds that will encourage exercise in the participants. The control group receives KP's usual care which is a combination of nutrition classes and web based learning.

Eligibility Criteria:
Inclusion Criteria:

* BMI greater than 30
* African American
* 40-46 years old

Exclusion Criteria:

- bariatric surgery within the previous 5 years
Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras

This is a single-arm, open-label, phase II clinical study to evaluate the safety and efficacy of thymic peptides in the treatment of hospitalized COVID-19 patients in Honduras.

This study was approved and registered by the Dirección General de Vigilancia del Marco Normativo de la Secretaría de Salud de Honduras (General Directorate for Regulatory Framework Surveillance of the Ministry of Health of Honduras) the eight of February of 2021; enrollment began tenth of February of 2021.

The study will analyze 23 clinical parameters, 9 laboratory studies besides complete blood count, chest radiography, time to response, adverse clinical outcomes, and hospital length of stay in 22 participants treated with a daily oral dose of 250 mg of lyophilized thymic peptides dissolved in 50 mL of water (one hour before or two hours after a meal) in addition to the standard treatment. A participant-level comparison based on registry data from Hospital de Santa Bárbara Integrado will be performed after propensity score matching. The Generic Assessment of Side Effects in Clinical Trials (GASE) will be applied in addition to monitoring of treatment-emergent adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed case of COVID-19 by viral nucleic acid (RNA) detection, viral antigen detection, or detection of antibodies to the virus.
* Participants that require hospitalization under Honduran Ministry of Health Guidelines for Clinical Management of COVID-19 Adult Patients: Stage IIb, defined as a patient with or without risk factors that presents with warning signs (shortness of breath, tachypnea), and altered inflammatory parameters.
* Participants that present with at least one of the following: oxygen saturation level below 94 percent; complete blood count showing lymphopenia, neutrophilia, or both; positive C-reactive protein; chest radiography or CT scan with ground-glass opacities.
* Male or female at least 21 years old.

Exclusion Criteria:

* COVID-19 patients that do not require hospitalization under Honduran Ministry of Health Guidelines for Clinical Management of COVID-19 Adult Patients: phase IA (asymptomatic), phase IB (mild symptoms without risk factors), or phase IC (mild symptoms with risk factors).
* Participants currently in other clinical trials evaluating experimental drugs.
* Known history of allergic reactions to thymic peptides or calf thymus acid lysate derivatives.
* Organ transplant recipients.
* Women who are pregnant or breast feeding.
The Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) in Advanced Hepatocellular Carcinoma (HCC)

To evaluate the efficacy of HAIC combine Lenvatinib and Durvalumab (HILL) in advanced HCC.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old and younger than 75 years; ECOG PS≤1; proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; cannot accepted hepatectomy; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent;

Exclusion Criteria:

* cannot tolerate HAIC or lenvatinib or durvalumab; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy;
Retrospective Study on the Incidence and Management of Anemia in Oncology

The incidence of anemia ranges from 20 to 75% depending on the type of cancer. It is often present at diagnosis and increases with specific treatments. It has an impact on overall survival and quality of life. Its origins are multiple (pure iron deficiency or functional, malnutrition, dyserythropoiesis, insufficiency renal, hemolysis, chemotherapy, radiotherapy, targeted therapies).

Transfusion is the most common treatment offered in the management of anemia. The incidence of anemia and its consequences are often underestimated during cancer management.

Recommendations were published in 2012. An inventory of the incidence of anemia before and after the publication of these recommendations are proposed in order to assess their impact on daily practice.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* Follow-up for cancer justifying hospitalization,
* Presenting anemia defined by a hemoglobin level \<11 g / dL,
* Patient not having objected to the collection of his data after oral and written information.

Exclusion Criteria:

* patients with a hemoglobin level ≥ 11 g / dL,
* adult patients under guardianship, curatorship or deprived of liberty,
* pregnancy or breast-feeding in progress at the time of hospitalization.
Study of Cerebral MRI Anomalies in Mutated Transthyretin Amyloidosis Patients

Transthyretin amyloidosis (aTTR) initially described as a rare disease, became the most serious hereditary polyneuropathy of adult onset and family screening has made it possible to identify and follow up many asymptomatic patients and carriers of the mutation in the TTR gene.

Considered as a systemic disease with involvement of target organs (the heart, the eye, the kidney and peripheral nervous system), it seems to be more complex for neurologists according to recent publications raising the issue of central nervous system involvement.

Indeed, TTR amyloid deposits seem to be correlated with the duration of the disease. These deposits can cause cortical damage by different mechanisms: direct TTR toxicity or as a result of pathology related to cerebral amyloid angiopathy (intraparenchymal or subarachnoid hematomas, small infarcts, hemosiderin). A small number of mutations in the TTR gene cause a rare phenotype of systemic amyloidosis, the oculoleptomeningeal form, characterized by clinical neurological symptoms: progressive dementia, epilepsy, ataxia, spastic paraparesis, stroke-like episodes.

Hypothesis of the work: the central nervous system involvement is probably underestimated on the radiological description in patients with TTR mutation.


Eligibility Criteria:
Inclusion Criteria:

* patients followed at the University Hospital of Nîmes between 2017 and 2021 for a TTR neuropathy with proven mutation, having benefited from a brain MRI.

Exclusion Criteria:

* Patients without TTR neuropathy with proven mutation, or who did not have a brain MRI.
Gestational Diabetes

Due to a changed lifestyle with less physical activity, unfavorable diets rich in fat and calories and obesity, the prevalence of diabetes mellitus is increasing worldwide. The diabetes epidemic is associated with significant personal and socio-economic consequences. Despite attempts to prevent the complications of diabetes, this disease is still the leading cause of blindness, chronic renal insufficiency and non-traumatic amputation. It is important to detect early on an increase in blood sugar and treat it accordingly to reduce costs and to minimize the personal suffering of those affected. As the number of patients with type 2 diabetes mellitus continues to rise, the number of young women with gestational diabetes mellitus (GDM) also increases. This is a disorder og glucose metabolism, which occurs for the first time in pregnancy. The causes for this are manifold. Among other causes, the increasing age of the mothers and weight gain during pregnancy are risk factors for gestational diabetes. Although it has been recommended that women with gestational diabetes should be re-examined after the birth of their child, many women have not. The study is a follow-up study to clarify whether insulin secretion disorder in women with and after GDM is a risk factor for the occurrence of type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

- Signed and dated informed consent

Enrollment is possible during AND after gestation:

* Baseline visit (pregnancy): gestational week 24+0 till 31+6
* Postpartum visits: documented occurence of GDM in previous pregnancy

Exclusion Criteria:

* Age \< 18years
* Diabetes Mellitus Type 1 or Type 2
* GFR \< 60 ml/min/1,73 m2
* CRP \> 1 mg/dl
* Increased levels of transaminases 2 fold above ULN
* Preexisting cardiac conditions
* Weight loss \> 10% within 6 months prior to inclusion
* Psychiatric disorders
* Chronic alcohol or substance abuse
* Blood sugar increasing or decreasing drug therapy, e.g. steroids, antidiabetics, insulin
* only postpartum visits: pregnancy or lactation
Prevalence of Partial Edentulism Among Patients of Faculty of Dentistry Cairo University

The patterns of tooth loss are evaluated in many selected populations in numerous countries and so the frequency of partial edentulism seems to vary widely between different countries.

The prevalence of various patterns of partially edentulous arches should be frequently revised and updated .

This could help identify the changing treatment needs of the population and provide guidelines to prevent tooth loss emphasis should be placed on dental education, improve the quality of prosthodontic care being provided to patients oral and general health promotion which should highlight the control of common oral diseases such as caries at their various stages of progression and periodontal diseases.

Additionally, regular dental check-ups should be made mandatory at schools, colleges and workplaces and community field trips should be conducted in order that increase in oral health awareness can also discourage patients attitude waiting until acute symptoms develop.

According to our knowledge, no available studies investigated the prevalence of partial edentulism among patients in faculty of dentistry Cairo university. Therefore, this study wouldbe of valuable information to oral health planners for proposing strategies that will help dentalhealth care management in faculty of dentistry Cairo,

study will be conducted on Patients above age of 20 years irrespective of sex, race, socioeconomic status having partially edentulism in either or both the arches to detect incidence and occurence of partial edentlism then detect its prevalance

Eligibility Criteria:
Inclusion Criteria:

* Study population who satisfied following criteria were included in the study:

  1. Patients above age of 20 years irrespective of sex, race, socioeconomic status having partially edentulism in either or both the arches
  2. Individuals who are willing and cooperative for study

Exclusion Criteria:

1. Completely edentulous patients,
2. patients with teeth extracted for orthodontic purpose
3. Patients with an only missing third molar, un erupted or congenitally missing teeth, root tips,and loose teeth that were indicated for extraction were not included in the study.
Effect of FID 114675A on Lens Wettability

The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or age or older with normal eyes, other than correction for refractive error.
* At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
* Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
* Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
* Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
* Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
* History or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* Participation in any investigational study within the past 30 days.
* Other protocol-defined exclusion criteria may apply.
Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients

Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly controlled Type 2 diabetes patients. This study is designed to understand the pharmacological effects and genetic variation of incretin based therapy on type 2 diabetes.

Background:

Since GLP-1 receptor is encoded by GLP1R ( glucagon-like peptide-1 receptor) gene, individuals may veritably respond to incretion based treatment, depending on the presence or absence of minor alleles characterized by single nucleotide polymorphisms. The genotyping of patients will be performed to compare the genetic factors and the pharmacological effects.

Expected Results: How to select a anti-diabetic drug tailored to the individual becomes more and more important because the enormously increasing classes of treatment modality. This study could be of great help in recommending the best possible agent for an individual, improving the possibility of treatment success, and justifying if the need of expensive drugs in a given patient.

Eligibility Criteria:
Inclusion Criteria:

* i) Age \> 20 years old ii)DM (diabetes mellitus) diagnosed \> 2 years iii)HbA1c level of 8% to 12% iv) Receiving incretin based therapy at least one month (including either GLP-1 agonist or DPP(dipeptidyl peptidase)-IV inhibitor

Exclusion Criteria:

* Type 1 Diabetes Mellitus
Next Generation Cataract and Vitreoretinal Surgery Study

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability and to collect formal user feedback.

Eligible subjects will be expected to attend 6 scheduled visits (Day -30 to 0 Screening, Day 0 Operative, Day 1 Postoperative, Week 1 Postoperative, Month 1 Postoperative, and Month 3 Postoperative) for a total individual duration for participation of approximately 4 months. One eye (study eye) will undergo ophthalmic surgery.

Eligibility Criteria:
Key Inclusion Criteria:

* Requires posterior segment surgery in the operating room with or without simultaneous cataract surgery;
* Clear media except for cataract and vitreous hemorrhage;
* In simultaneous cataract and vitreoretinal surgery, eligible to undergo primary hydrophobic acrylic intraocular lens (IOL) implantation into the capsular bag;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Previous vitrectomy in the operative eye aside from those requiring silicone oil removal;
* Neovascular or uncontrolled glaucoma;
* Planned glaucoma or postoperative surgeries during study aside from silicone oil removal;
* Inadequate pupil dilation (less than 6 millimeters);
* Other protocol-defined exclusion criteria may apply.
Phase I Dose Escalating Study of TKI258

The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained prior to any screening procedures
* Advanced solid tumors
* Agreement to remaining hospitalized
* ECOG performance status of 0 or 1
* Life expectancy of at least 3 months
* Pregnant women. Male and female patients of reproductive potential must agree to employ an effective method of birth control
* Demonstrate the specific hematological /blood chemistry laboratory values

Exclusion Criteria:

* Receipt of any investigational compound within 28 days prior to the first dose of study drug or failure to have recovered from the side effects of such prior therapy
* Receipt of other antineoplastic therapy, including chemo-, hormonal, immuno-, and radiation therapy, within 28 days (with some exceptions)
* Patients with CNS and/or leptomeningeal disease metastases
* Presence or history of thromboembolic or cerebrovascular events
* Impaired cardiac function or clinically significant cardiac disease
* Malabsorption syndrome or uncontrolled gastrointestinal toxicities
* Patients known to be HIV- or HBV- or HCV- positive
* Patients with acute or chronic uncontrolled infection
* Patients who have undergone surgery with general anesthesia for any cause within 28 days prior to the first dose of study drug
* Patients who have been receiving anticoagulant therapy
* Receipt of any hematopoietic colony stimulating factor or blood transfusion within 14 days prior to the first dose of study drug
* Patients who have been administering concomitant medication which may prolong the QTc interval
* Patients with interstitial pneumonia or pulmonary fibrosis proven on a chest CT scan
* Patients with a large volume of ascitic and/or pleural fluid which requires drainage
* Patients with any bone fractures
* Deemed otherwise unsuitable by the investigator

Other protocol-defined inclusion/exclusion criteria may apply
Use of Disposable Spirometer for Recovery of Pulmonary Function

We hypothesize that the addition of modified incentive spirometry to standard postoperative chest physiotherapy will be associated with faster return to baseline/predicted pulmonary function and fewer postoperative pulmonary complications in patients following laparotomy.

The primary objective of this study is to determine how quickly patients' peak expiratory flow measurement returns to baseline or predicted values following laparotomy with or without the assistance of modified incentive spirometry. The secondary objective is to assess the effectiveness of modified incentive spirometry in preventing postoperative pulmonary complications in patients following laparotomy. Specifically, this study will track length of stay, mortality, and evidence of pulmonary infection in both treatment and non-treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who undergo laparotomy at Kamuzu Central Hospital, Malawi

Exclusion Criteria:

* Patients with known pre-existing pulmonary disease
* Pregnant women
* Patients who cannot perform maximal expiration for measurement of peak expiratory flow meter because of inability to understand or follow directions and demonstrations
* Patients with terminal cancer or illness with life-expectancy less than 1 month
* Patients with burn injuries
* Patients with illness requiring intubation and mechanical ventilation or postoperative ICU admission
* Patients who require additional operations during the course of their hospital stay