cyrilzakka/clinical-trials huggingface dataset:
Use of Chamomilla Recutita in Phlebitis

To verify the efficacy of topical applications of Chamomilla recutita infusion for phlebitis treatment, before dose response curve study and pilot study.

The hypothesis adopted was that patients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy, treated with a compress of Chamomilla recutita infusion for 20 minutes three times per day, would present a shorter phlebitis regression time in comparison with patients treated with a lukewarm water compress.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with cancer who had infusion phlebitis during the administration of intravenous chemotherapy peripheral under hospitalization.

Exclusion Criteria:

* Report made by the subject of study, prior hypersensitivity reaction or presentation during the research, adverse reaction to chamomile or any plant of the family Asteraceae ou Compositae: margarida (Aster tripolium), crisântemo (Chrysanthemum leucanthemum), artemísia or isopo santo (Artemísia vulgaris), carpineira or ambrósia americana (Ambrosia artemisiifolia) and senécio (Senecio jacobaea L.);
* Prescription during the process of data collection, some kind of anti-inflammatory with systemic or topical activity where it was located phlebitis, and, upon the occurrence of bacterial phlebitis, had been prescribed topical or systemic antibiotic therapy;
* Refusal of the subject to participate in the study, regardless of the time.
Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection

This is a Prospective, Randomized, Multi-center, Open label, Phase 1/2 study to Evaluate the Safety and Efficacy of Equine COVID-19 Antiserum \[F(ab')2\].

BSV has developed Equine COVID-19 antiserum from horse serum for the use in COVID-19 infection. The indication proposed is to provide passive immunization to the COVID-19 infected patient thereby reducing the viral load and prevention of disease progression.

Clinical phase 1 and phase 2 studies have been planned to be conducted. The phase 1 study will be conducted on two dosages to find the safety and tolerability in patients. Based on the results of phase 1 study the phase 2 shall be initiated.


Eligibility Criteria:
Inclusion Criteria:

1. Age Phase 1: ≥ 18 years to ≤ 55 years Phase 2: ≥ 18 years to ≤ 65 years
2. Are male or non-pregnant females who agree to contraceptive requirements.
3. Patients with RT-PCR confirmed COVID-19 in ≤ 72 hours prior to randomization \[Ct ≥ 24\].
4. Have SpO2\<94% (range 90-93%) on room air.
5. Have one or more of the following- dyspnea, fever, cough, respiratory rate ≥ 24 per minute and heart rate up to 120 per minute.
6. Patients who agree to participate in the study and follow all study related procedures

Exclusion Criteria:

1. Require mechanical ventilation
2. Have oxygen saturation less than or equal to 89 percent
3. Patients re-infected with SARS-CoV-2
4. Suspected or proven serious active bacterial fungal viral or other infection
5. Patients with positive skin test with IP
6. Patients with known equine allergies or past medical history of serum sickness
7. Patient who are HIV, HCV, HbsAg positive or immunocompromised
8. Patients with significant co-morbidities at screening
9. Moribund state
10. Pregnant or nursing women
11. Participating in other clinical trial
Efficacy, Safety, and Pharmacokinetics of QAW039

This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a medical history of mild to moderate persistent allergic asthma.
* Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of \>17 kg/m2.
* Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception

Exclusion Criteria:

* Women of child-bearing potential.
* Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
* Patients with severe persistent asthma

Other protocol-defined inclusion/exclusion criteria may apply.
The Study of Post-operation Delirium and Prognosis of Cardiac Surgery Patients

Delirium is the most common neurological complication of cardiac surgery patients and associated with poor prognosis. In recent years, the important role of quantitative electroencephalogram (qEEG) in brain function monitoring is becoming increasingly prominent. The purpose of this study is to evaluate the effect of qEEG in predictive of post-operation delirium and prognosis of cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

1. The patients of cardiac surgery aged ≥18 years
2. Signed informed consent

Exclusion Criteria:

1. Patients with a history of any neurologic and psychiatric disease
2. Cognitive disorder
3. Stroke history in three years
COVID-19 Infection and Reproductive Health in Infertile Women

An increased number of women has been infected by COVID-19 in the last 2 years SARS-CoV-2 infection could have a role in potential disturbances on hormon levels and human fertility Has not completely demonstrated COVID-19 effects on female reproductive function and further research can be undertaken.

The proposed multicenter study will be simple and rapid, and attractive for the scientific community.

COVID-19 virus is classified as a respiratory disease that drastically changed our daily life and perspective (1) can be mainly transmitted via respiratory droplets, however, there are recently published reports suggested its ability to transmit via sexual intercourse, assisted reproductive technology (ART) treatments, pregnancy, and nursing. ART specialists should be precautious, carefully following the situation while contributing by sharing novel evidence to counsel our patients (2).

However, there are no comprehensive reviews to explore the association between COVID-19 and female fertility comprehensively.Its of major importance to provide in-depth research explaining the underlying mechanism of SARS-CoV-2 infection and its impact on human reproductive organs and fertility (3).

Ovarian reserve is a key determinant of female fertility. In this study we observe the potential effects of SARS-CoV-2 infection on the principal indicators of ovarian reserve function as anti-Müllerian hormone (AMH); basal follicle-stimulating hormone (FSH), basal luteinising hormone (LH) basal oestradiol (E2) antral follicle count (AFC).

Questions regarding the potential risks of sexual transmission during intercourse and/or application of ART, vertical transmission (throughout pregnancy, delivery, and breastfeeding), the health of pregnant and postpartum women, and fetal or postnatal health problems of neonates/children remain largely unanswered (4,5).

Eligibility Criteria:
Inclusion Criteria:

Women 24-43 years of age Previous history of COVID-19 infection INFERTILITY DIAGNOSIS

Exclusion Criteria:

Women with current symptoms of COVID-19 infection Positive for HIV or the presence of active viral hepatitis Previosuly ovarian cancer, removal of ovaries or gonadotoxic treatments
Brief Intervention Study for Quitting Smoking

To investigate the effectiveness of a smoking cessation intervention of two sessions (120 min at a time) in a group setting on the basis of Motivational Interviewing (MI) and important elements of Cognitive Behavioural Therapy (CBT). According to national and international guidelines patients are advised to quit and pharmacologically supported with one of the established first line smoking cessation treatments.

The study design is multicentric, prospective, randomized and controlled. The study is taking place in cooperation with smoking clinics of 5 centres in Germany (Heidelberg, Stuttgart, Munich, Chemnitz, Berlin). A total number of 800 smokers is calculated to participate in the study. After enrollment participants are randomized in one of the three intervention groups: (A) "Advice only", (B) "Brief intervention", (C) "Intensive therapy". The follow up includes a telephone interview 3 months after the last intervention, and two visits at the smoking clinics after 6 and 12 months with biochemical validation of the smoking status by measurement of the exhaled carbon monoxide and the concentration of cotinine in an urine sample respectively. The primary endpoint is the continuous abstinence rate after 12 months. Several secondary endpoints are determined amongst others the continuous abstinence rate after 6 months, point prevalence cessation rates after 6 and 12 months, life quality, weight gain, predictors of a successful cessation attempt.

Eligibility Criteria:
Inclusion Criteria:

* Smoker
* Age \> 18 years
* Motivation to quit smoking

Exclusion Criteria:

* severe somatic comorbidity or reduced life expectancy
* severe episode of a psychiatric disease
* reduced cognitive ability
* abuse of alcohol or illicit drugs
* other reasons at the discretion of responsible local study tutor
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects.

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HIP1801 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19\~45 years in healthy male volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator
Trial on Three Eating Disorders Group Treatment

This trial aims at comparing three group treatments designed for eating disorders: a Cognitive-dissonance, a Mindfulness and a Person-centered based programs. Women with eating disorders will be recruited and randomized to one of the three programs. Participants will complete a pretest, a posttest, a 3-months follow-up and a 1-year follow-up. This trial aims to compare the programs to analyze the specific dimensions upon which each program acts. The investigators therefore made hypotheses according to the programs' theory: participants in the Cognitive-dissonance based program should experience a greater decrease in eating disorders symptoms, thin-ideal internalization and body dissatisfaction and a greater improvement in quality of life than other participants. Participants in the Mindfulness-based program should show a greater improvement in negative affect and in equanimity than other participants. Participants in the Person-Centered based program should report a greater increase in congruence than other participants.


Eligibility Criteria:
Inclusion Criteria:

* eating disorders (anorexia nervosa, bulimia nervosa or binge eating disorder) or other specified feeding or eating disorder (subthreshold of anorexia, bulimia or binge eating disorder) according to Diagnostic Statistical Manual 5
* to have no regular treatment (no more than one session per month) during the 8 weeks of the program
* participants with a Body Mass Index under 17.5 could be include in the study if they had a medical monitoring in another structure

Exclusion Criteria:

* a psychotic disorder
* a bipolar disorder
* a mental retardation
* to not read or speak French fluently
Mapping Auricular Vagus Nerve Circuitry

This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.

Scientific research into the basic mechanisms underlying neuromodulation is relatively recent and incomplete. The purpose of the proposed study is to determine how a form of neuromodulation, transcutaneous electro-accupoint stimulation, which is non-invasive and non-painful, affects human brain, stomach, and autonomic activity. We will accomplish this by integrating whole brain functional MRI (fMRI) methodologies with gastric MRI and physiological monitoring.

This study will comprise 3 functional magnetic resonance imaging (fMRI) brain-gut scans, all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65
* Functional dyspepsia

Exclusion Criteria:

* Any condition contraindicating an fMRI brain scan
Assessment of the Accuracy of Surgical Guide Designed From Digital Impression, Dental Model Scanning Using CBCT and Desktop Scanner in Computer Guided Implantology:

Assessment of the Accuracy of Surgical Guide Designed from Digital Impression, Dental Model Scanning using CBCT and Desktop Scanner in Computer Guided Implantology:

Randomized Clinical Trial.

Research question:

In computer guided Implantology, are surgical stents designed from scan of dental model by CBCT and from digital impression as accurate as surgical stents designed from desktop scanner?

Statement of the problem:

The role digital dentistry is improved in computer guided implantology especially with development of computer guided implant software, desktop scanner and intra oral scanner development and CBCT machines.

Intra-oral scanner, desktop scanner and CBCT scanner can be used in creation of 3D digital model that can be used with computer guided implant in fabrication of the surgical stent.

And the question, is the accuracy of surgical guide will be affected when designed by one of these different modalities?

Rationale for conducting the research:

Digital 3D dentoginival details are very important in computer guided implantology and designing of surgical stent.nowadays there are many methods to obtain this soft tissue replica as CBCT,desktop scanner and intra oral scanner.this study is conducted to asses the effect of different method of soft tissue digitization on the accuracy of surgical template used in computer guided implantology.

Eligibility Criteria:
Inclusion Criteria:

* partially edentulous patient.
* Patients with bucco-lingual bone thickness more than 6 mm allowing flapless implant placement.

Exclusion Criteria:

* Completely edentulous patient or Free end saddle edentulous area.
* Patients needing graft or sinus lifting with implant placement.
* Patients with thin ridges.
* Patients with systemic disease that may affect bone quality.
* Patients with poor oral hygiene and active periodontal diseases.
* Patient with limited mouth opening
Transnasal Humidified Rapid Insufflation System for Intubation

Transnasal humidified rapid insufflation ventilator exchange (THRIVE) or not during the anesthesia induction

Control group-usual mask ventilation during apnea for anesthetic intubation and check tube positioning THRIVE group-applying THRIVE during apnea for anesthetic intubation and check tube positioning

Eligibility Criteria:
Inclusion Criteria:

* Patients who scheduled for elective lung surery with one lung ventilation

Exclusion Criteria:

* suspicious difficult intubation (BMI \>35kg/m2, mouth opening \< 3 finger, Mallampati G \>3), Room air SpO2 \< 90%, active pulmonary infection, emergency operation, pregnancy
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.


Eligibility Criteria:
Inclusion Criteria:

* Male or female infants born at ≥34 weeks of gestation and who are 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered day of life 1).
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
* Major known congenital malformation or serious chronic disorder.
Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)

The purpose of this non-interventional study is to collect data on efficacy and toxicity of the use of Navelbine ORAL in daily routine in Germany (especially after availability of an 80mg capsule). The study focusses on concomitant antiemetic therapy and patient compliance.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Male and female patients
* Advanced NSCLC (Stage III or IV) or Antracycline-resistant MBC
* Therapy with Navelbine capsules in any palliative treatment line
* Signed patient informed consent

Exclusion Criteria:

* Pregnancy and nursing
* All other exclusion criteria listed in SPC (summary of product characteristics)
* lack of signed Patient informed consent
Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy

The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
* Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
* Presence of measurable disease

Exclusion Criteria:

* Progression on prior BTK or PI3K delta inhibitor
* Prior treatment with TGR-1202
* Richter's transformation or CLL transformation to aggressive lymphoma
Detection of Urinary Stones on ULDCT With Deep-learning Image Reconstruction Algorithm

Urolithiasis has an increasing incidence and prevalence worldwide, and some patients may have multiple recurrences. Because these stone-related episodes may lead to multiple diagnostic examinations requiring ionizing radiation, urolithiasis is a natural target for dose reduction efforts. Abdominopelvic low dose CT, which has the highest sensitivity and specificity among available imaging modalities, is the most appropriate diagnostic exam for this pathology. The main objective of this study is to evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in urolithiasis patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* Patient referred for abdominopelvic CT to confirm urolithiasis or for follow-up,
* Affiliation to a social security program,
* Ability of the subject to understand and express opposition

Exclusion Criteria:

* Age \<18 years old,
* Person under guardianship or curators,
* Pregnant woman,
* Any contraindications to CT
METRIC: Measurement, Education and Tracking in Integrated Care

The proposed study seeks to establish the feasibility of universal screening for depression in an adult primary care safety net setting, measure the effectiveness of a culturally appropriate depression education intervention to reduce stigma and increase uptake in depression treatment among Hispanics, and implement a Measurement-Based Integrated Care (MBIC) model with collaborative, multi-disciplinary treatment and culturally tailored care management strategies.

Specific Aim 1: Examine the specific effects of a Depression Education Fotonovela (DEF) to increase knowledge of depression, reduce stigma and increase engagement in depression treatment among Hispanic patients.

Specific Aim 2: Evaluate the impact of Measurement-Based Integrated Care (MBIC) for the treatment of depression in one community-based Federally Qualified Health Centers (FQHC) in North Texas whose patient population is majority Hispanic.

Specific Aim 3: Examine the feasibility of universal screening and accurate detection of depression among adult primary care patients utilizing innovative iPad Depression Screening technology.

Eligibility Criteria:
Inclusion Criteria:

* Adult primary care patients
* Hispanic
* Meets diagnostic criteria for depression

Exclusion Criteria:

* currently in treatment for depression
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in patients with cachexia caused by cancer.

PURPOSE: This randomized phase I trial is studying whether testosterone administered during standard of care chemotherapy and/or radiation works by helping patients with squamous cell carcinoma to maintain their body weight and muscle size and strength during treatment.

OBJECTIVES:

* To determine the effect of testosterone therapy on lean body mass and muscle strength in patients with advanced or recurrent squamous cell carcinoma.
* To determine the testosterone therapy on inflammatory biomarkers in patients with advanced or recurrent squamous cell carcinoma.

OUTLINE: Patients are stratified according to age and disease stage. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive standard of care chemotherapy and/or radiation and placebo testosterone intramuscularly (IM) weekly for 7 weeks.
* Arm II: Patients receive standard of care chemotherapy and/or radiation and testosterone IM weekly for 7 weeks.

Patients undergo dual energy x-ray absorptiometry, muscle strength tests, stable isotope metabolic studies, indirect calorimetry studies, and assessment of their physical activity level, and nutritional counseling. Patients also complete mood, fatigue, and quality-of-life questionnaires.

Blood, muscle tissue, and urine samples are collected periodically for laboratory studies. Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by immunoassay.

After completion of study treatment, patients are followed periodically for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent squamous cell carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Mini Mental State Examination score \> 23

Exclusion Criteria:

* Pregnancy
* Evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver enzymes
* Significant liver, renal, or heart disease
* Diabetes mellitus or other untreated endocrine disease
* Polycystic ovary syndrome and/or hyperthecosis
* Androgen secreting tumors of the ovary and adrenal or any ovarian tumors (e.g., Sertoli- Leydig cell tumor)
* Non-classical adrenal hyperplasia
* Cushing's syndrome
* Glucocorticoid resistance
* Hyperprolactinoma or hypothyroidism
* Lactose intolerance
* Alcohol or drug abuse
* Recent treatment (within 3 months) with anabolic steroids
* Ongoing anticoagulant therapy
* Any other circumstance that would preclude study participation, in the opinion of the principal investigator or study physician