cyrilzakka/clinical-trials huggingface dataset:
Treatment Trial of Thermoregulatory Disturbances in Adolescent Anorexia Nervosa Patients With Either Ginger Powder Footbaths or Warm Water Footbaths

A study to explore whether warm water footbaths with added ginger powder can improve thermoregulatory processes in adolescent anorexia nervosa patients and provide them with an increase in subjective feeling of warmth. The participants will receive a warm footbath four times a week for six weeks with a physiological and psychological testing point once before the beginning of the six-week footbath period and once after.

This is a two-arm randomized controlled trial to evaluate the efficacy of warm water footbaths with added ginger powder (experimental) compared to warm water only footbaths (control) in adolescent anorexia nervosa patients. Participants will receive footbaths 4 times per week before bed-time over a period of six weeks.The main focus is on subjective increase in overall body warmth. Moreover, core body temperature, skin temperature at the extremities and several psychological as well as physiological scores and parameters are assessed before and after the six-week intervention. A follow-up is planned at six months post intervention, where core body temperature, physiological and psychological parameters are once more tested.

Eligibility Criteria:
Inclusion Criteria:

* main diagnosis: Anorexia nervosa
* written informed consent of participants and legal guardians

Exclusion Criteria:

* other eating disorder diagnosis apart from Anorexia nervosa
* known allergic reaction to ginger
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of mild to moderate erosive Gastroesophageal Reflux Disease (GERD).

Eligibility Criteria:
KEY INCLUSION CRITERIA:

1. Male or female, ages 18 to 75 years.
2. History of gastroesophageal reflux disease (GERD) symptoms for at least 3 months immediately before screening.
3. Heartburn for at least 2 days a week for at least 1 month before screening.
4. Esophageal erosions of Los Angeles (LA) Grades A or B based on EGD taken within 14 days prior to enrollment.
5. Subjects who are H. pylori negative based on a screening test.
6. Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception.
7. Subjects must be able to read, write, and understand the language of the symptom diary.

KEY EXCLUSION CRITERIA:

1. Current or a history of esophageal motility disorders.
2. Current or a history of Barrett's esophagus. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).
3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
4. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
5. Inflammatory bowel disease.
6. Unstable diabetes mellitus.
7. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\>=20 mg/day prednisone or equivalent), or aspirin (\> 325 mg/day).
The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Human Adipose Tissue: An In Vivo Study

Study part-1

GIP (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones secreted by specialized cells of the gastrointestinal tract in response to ingestion of nutrients. Data emerging from studies in animal models and cultured human fat cells support a physiological role for GIP in the adipose tissue metabolism which may contribute to the pathogenesis of obesity.

The proposed study will shed more light on the interactions between gut hormones and adipose tissue. For this pilot study, male subjects fulfilling the inclusion criteria will be given GIP or placebo infusions in a randomized manner. Fat tissue biopsies will be obtained from all subjects during both visits, once in the basal state (before the start of the peptide/placebo infusion) and then repeated at the end of the period of infusion.

Study part-2

Surgery represents the most effective therapeutic modality for morbid obesity. Resolution of type 2 diabetes mellitus (T2DM) has been consistently observed as an additional benefit of surgical treatment of obesity. The mechanisms underlying the dramatic effects of surgery on insulin sensitivity and β-cell function are poorly understood. Bariatric surgery (gastric bypass) promotes changes in the enteroendocrine system as a result of nutrient diversion from the physiological intestinal routes with subsequent profound modification of gut hormone secretion

We hypothesize that restoration of GIP action after bariatric procedures plays a cardinal role in the improvement and/or restoration of diabetes, we propose to study patients (both sex)with morbid obesity and T2DM within 3 months after their surgery. Their responses will be compared to those of BMI matched control subjects with normal glucose tolerance


Eligibility Criteria:
Inclusion Criteria:

* Lean (BMI 20-25 kg/m2) subjects with normal glucose tolerance
* Obese (BMI \>30 kg/m2) subjects also with normal glucose tolerance.
* Obese with impaired glucose tolerance
* Obese with diet controlled diabetes mellitus
* Morbid obesity, type diabetes and post bariatric surgery (study part 2)

Exclusion Criteria:

* History of severe cardiac, hepatic or renal disease
* Thyroid dysfunction (hyper-or hypothyroidism), or other endocrine disturbance (acromegaly, growth hormone deficiency, hypoadrenalism or cortisol overproduction)
* Current malignant disease
* Known alcohol misuse
* Major psychiatric disease (including current use of antidepressants)
* History of major eating disorder (anorexia or bulimia nervosa)
Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Coronary Artery Disease (HERCET-Study)

Patients with coronary artery disease are characterized by an increased cardiovascular risk and they often have low blood high density lipoprotein (HDL)-cholesterol levels or HDL-cholesterol with modified vasculoprotective properties.

The purpose of the present study is to characterize the quality of HDL-cholesterol in patients with coronary artery disease and normal blood HDL-cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-cholesterol in these patients. Additionally, the researchers aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with coronary artery disease and the changes dependent on physical activity of patients.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease
* Normal HDL-cholesterol levels in blood:

  * \> 40 mg/dl (1.03 mmol/L) in males
  * \> 50 mg/dl (1.29 mmol/L) in females

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus
* Acute coronary syndrome
* Unstable angina pectoris
* Myocardial infarction during the last 8 weeks
* Therapy with niacin
* Active infections
* Ventricular arrhythmias
* Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg
* Cancer
* Pregnant or lactating
* Alcoholism
Ultrasound Image Quality of the Brachial Plexus at the Interscalene Space Before and After Shoulder Arthroscopy

Ultrasound guided interscalene nerve blockade with local anesthesia is a standard regional anesthetic technique for providing postoperative analgesia during shoulder arthroscopy and wide variety of shoulder procedures. There is a paucity of data regarding the effects of shoulder arthroscopy on ultrasound image quality, including the effects of muscle mobilization and the use of large volume irrigation and subsequent tissue absorption, though increased neck circumference and airway edema are known complications of arthroscopic shoulder procedures.

The objective of the study is to determine if there is a difference in ultrasound image quality of the interscalene block anatomy, by Likert scale, pre- versus post-operatively in a cohort of patients undergoing shoulder arthroscopy who routinely receive blockade of the brachial plexus for postoperative analgesia. Further, if there are differences in imaging quality, correlations with surgical and patient factors will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Subject is undergoing shoulder procedures involving arthroscopy
* Subject has consented to interscalene blockade for postoperative analgesia

Exclusion Criteria:

* Patient refusal
* Contraindications to interscalene blockade, including significant pulmonary insufficiency, hemi-diaphragmatic paralysis, brachial plexus or degenerative neuropathy
* Allergy to proposed local anesthetic medication\\
* Severe cervical spine disease.
* BMI \>40 kg/m2
* Neck Circumference \> 50cm
* Failed preoperative interscalene blockade
* Patients known to be currently pregnant or actively breastfeeding
* Patients where English is a language barrier
Assessment Of Safety And Efficacy Of SU11248 In Patients With Metastatic Colorectal Cancer Who Have Failed Selected Previous Treatments.

Assessment of safety and efficacy of SU11248 in patients with metastatic colorectal cancer who have failed selected previous treatments.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer
* Failed selected cancer therapies in the past.

Exclusion Criteria:

* Prior treatment with tyrosine kinase inhibitors or VEGF inhibitors other than bevacizumab.
One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma

This non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.


Eligibility Criteria:
Inclusion Criteria:

* Completed the 2-79-52030-207 study and received 12 injections of lanreotide Autogel 120 mg, regardless of efficacy at the end of this period.
* Subject or in case of subject's death next of kin having given their written informed consent prior to collection of the data by the sponsor (if locally required)
Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars

The aim of the present study is to evaluate Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.

Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database in Pediatric Dentistry department.

A total of 150 primary molars from healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain shams University.

Subjects will be assigned randomly into two different treatment groups as follows:

MTA Group (1):

1. Group 1(A): MTA Direct Pulp Capping. (n=25)
2. Group 1 (B): MTA Partial Pulpotomy. (n=25)
3. Group 1 (C): MTA Complete Pulpotomy. (n=25)

BiodentineTM Group (2):

1. Group 2(A): BiodentineTM Direct Pulp Capping. (n=25)
2. Group 2 (B): BiodentineTM Partial Pulpotomy. (n=25)
3. Group 2 (C): BiodentineTM Complete Pulpotomy. (n=25)

Eligibility Criteria:
Inclusion Criteria:

* No clinical symptoms or history implying irreversible pulpitis such as spontaneous pain, or pain persisting after stimuli removal.
* Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess.

Exclusion Criteria:

* Children who are extremely uncooperative and difficult to manage.
* Children suffering from any physically or mentally disability that will complicate the treatment: Special Health Care needs (SHCN).
* Teeth of poor prognosis due to presence of an abscess or a sinus, mobility, advanced bone or root resorption or Non-Restorable teeth.
Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression

The goal of this clinical trial is to demonstrate the benefit of a standardized immunotherapy (Interferon gamma) on the incidence of secondary infections. . It will also learn about the safety of Interferon-gamma. The main questions it aims to answer are:

Does Interferon-gamma:

* reduces the Incidence of secondary infection episodes at three months
* reduces the ICU mortality and at Day 90
* reduces the ICU and hospital length of stay
* induces Biological immune restoration at Day 10
* has cost-consequence and cost-effectiveness

Researchers will compare Interferon-gamma to a placebo (a look-alike substance that contains no drug) to see if Interferon-gamma works to treat sustained immunosuppression .

Participants will:

* Take Interferon-Gamma or a placebo for a maximum of 5 times between day 1 and day 9
* be monitored evety day until their ICU discharge and at day 30, 60 and 90


Eligibility Criteria:
Inclusion Criteria:

* Adult patient hospitalized in the ICU for at least 1 week
* Expected length of stay in the ICU greater than 1 week at screening
* At least 1 episode of multiple organ failure, defined as a SOFA ≥ 6 (excluding the respiratory component when related to a neurological failure), during the first 1 week of ICU hospitalization
* Immunosuppression defined as an mHLA-DR \< 8000 Ab/c and a lymphopenia \< 1000/mm3 within a 96 hours time window
* Consent from family members or patient

Exclusion Criteria:

* Ongoing secondary infection at screening
* Participation in another research clinical trial within 30 days
* Chemotherapy / radiation therapy within the last 6 weeks
* Apache II ≥ 30 at screening
* History of autoimmune disease
* Organ or bone marrow transplant
* History of hematologic malignancy
* History of hepatitis C
* HIV stage C within the last 12 months
* Patients under legal protection
* History of or ongoing tuberculosis
* Chronic hepatitis B
* Patients receiving immunosuppressive medications (see appendix 1)
* Pregnancy or breast feeding
* Subjects with a history hypersensitivity to interferon gamma or excipient or other interferon
* Hepatic cytolysis with AST/ALT \> 5 times ULN (local laboratory)
* Suspected acute pancreatitis with lipase or amylase \> 3 times ULN (local laboratory)
* Severe chronic renal failure (eGFR\<10 ml/min/1.73m2 CKP-EPI method)
A Phase 3 Clinical Study of KW-3357 in Patients With DIC

To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC criteria.


Eligibility Criteria:
Inclusion Criteria:

* Japanese Association for Acute Medicine-defined DIC criteria score \>= 4
* Antithrombin activity \<= 70%
* Written informed consent from patient or guardian

Exclusion Criteria:

* Anamnesis or complication of serious drug allergy
* Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis
* Pregnant, nursing, or possibly pregnant woman
* Possibility for the promotion of bleeding by concomitant use of heparin
Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

This study will compare the safety and efficacy of a tigecycline regimen versus an imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from a minimum of 7 \& up to 14 consecutive days, the exact duration will be at the decision of the investigator based on the subject's condition. Additional protocol specified antibiotics may be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit will be done 10 to 21 days after the last day of therapy. The total duration of subject participation will be between 17 and 44 days, including a follow up period of 30 days after the last day of therapy for SAEs.

Subjects will be followed for safety and efficacy. The safety assessment will include: physical examinations, vital signs, assessment of the clinical signs and symptoms of pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology, serum chemistries, and coagulation parameters, \& a serum or urine pregnancy test before study entry for women of childbearing potential. The clinical and microbiological efficacy will both be evaluated.

The sponsor internal decision has been taken to close the study on 15 of July 2011, due to difficulties in enrollment. This decision was not based on any safety issues.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, greater than or equal to 18 years of age, known or suspected to have acute hospital-acquired pneumonia (HAP).
* Acute HAP is defined as pneumonia with onset of symptoms:

  1. Greater than or equal to 48 hours after admission to an acute care hospital or chronic care facility such as a skilled nursing home facility or rehabilitation unit. Or
  2. Less than or equal to 7 days after the subject was discharged from the hospital. The initial hospitalization must have been greater than or equal to 3 days duration.
* VAP is defined as: onset of symptoms of pneumonia greater than or equal to 48 hours after endotracheal intubation.
* Presence of a new or evolving infiltrate on a chest x-ray film, presence of fever or leukocytosis, respiratory failure requiring mechanical ventilation or presence of 2 of the following clinical signs and symptoms: cough, dyspnea or tachypnea, pleuritic chest pain, rales and/or evidence of pulmonary consolidation, hypoxemia, or purulent sputum production.

Exclusion Criteria:

* Subjects with other significant underlying conditions that would make it difficult to evaluate the subjects or make it unlikely to complete the therapy or that would increase their risk by participating in the study, infection with organisms known to be resistant, contraindication, or hypersensitivity to any of the test articles.
A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis

The study will follow a parallel arm, randomised, double blinded, placebo controlled design.

There will be two groups Group 1 = receiving 1% curcumin chips after routine scaling and root planing (n=20) Group 2 = receiving placebo chips after routine scaling and root planing (n=20) Clinical parameters: ( Baseline, 4 weeks, 12 weeks) Probing pocket depth, clinical attachment level, gingival index, plaque index Cytokine parameter ( Baseline, 4 weeks) Interleukin 1 beta in GCF

Statistical analysis Repeated measures of ANOVA Paired t-tests


Eligibility Criteria:
Inclusion Criteria:

1. Systemically healthy individuals
2. Presence of a minimum of 20 teeth in the oral cavity
3. Localised periodontal pockets with probing depths greater than 4mm i.e., Periodontitis in its stages 2 and 3, as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology (AAP)

Exclusion Criteria:

1. Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose
2. Systemic diseases and/or Inflammatory conditions, Obesity
3. Former or current tobacco users
4. Chronic consumption of alcohol
5. Use of anti-inflammatory drugs and antibiotics over the past 3 months
6. Periodontal therapy in any form, surgical or non surgical in the past 6 months
7. Pregnant and lactating mothers
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia

Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.

Patients scheduled for peripheral vascular examination and healthy controls will be measured with the FlowMet-R, a noninvasive blood flow monitor, and compared to gold standard diagnostics - ABI, TBI, and Doppler Ultrasound. Sensitivity and specificity of the FlowMet-R device output in diagnosing PAD and CLI will be assessed on initial visit, 3-month followup, and 6-month followup.

Eligibility Criteria:
Inclusion Criteria:

PAD Positive Cohort

* Subject meets PAD positive criteria
* Subject is willing and able to provide informed consent
* Subject is willing and able to comply with study procedures
* Subject is able to understand the study procedures
* Subject is scheduled for vascular examination that includes noninvasive assessments as standard of care: ABI, TBI, and either a Duplex Ultrasound or Angiogram

Healthy Cohort

* Subject is willing and able to provide informed consent.
* Subject is willing and able to comply with the study procedures.
* Subject is able to understand the study procedures.
* Subject has no history of positive PAD diagnosis, and is not currently suspected of having PAD.

Exclusion Criteria:

PAD Positive Cohort

* Subject is under 40 or unable to consent.
* Subject has any medical condition, which, in the judgment of the Investigator and/or designee, makes the subject a poor candidate for the investigational study.
* Subject is excluded from analysis if no stenosis is found during Doppler but Tibial disease is suspected and Tibial ultrasound is not able to be performed.
* Subject does not have a suitable finger to attach the FlowMet-R probe.
* Subject does not have a suitable 1st or 2nd digit to attach FlowMet-R probe on the limb of interest.
* Subject has undergone revascularization within the last 90 days
* Subject cannot lay safely in a supine position.

Healthy Cohort

* Subject is under 40 or unable to consent.
* Subject has any medical condition, which, in the judgment of the Investigator and/or designee, makes the subject a poor candidate for the investigational study.
* One or more limbs has a prior or current diagnosis of PAD, or is reasonably suspected of having a diagnosis of PAD.
* Subject does not have a suitable finger to attach the FlowMet-R probe.
* Subject does not have a suitable 1st or 2nd digit to attach FlowMet-R probe.
* Subject has undergone revascularization within the last 90 days
Oral Care With Breast Milk in Preterm Newborns Fed by Tube

It was conducted to evaluate Oral Care with Breast Milk in Preterm Newborns Fed by Tube

Newborns selected according to the randomization group will receive nursing care, including oral care and feeding, from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon. Breast milk (BM) will be used for oral care. At each treatment, two ml BM should be dropped onto sterile gauze to clean the cheeks, tongue and palate. Process steps; After hand hygiene is achieved, it will be done using disposable gloves.

Eligibility Criteria:
Inclusion Criteria:

* -Staying in the neonatal intensive care unit
* Being fed by gavage
* Babies with no oral intake (nonperoral-NPO)
* Babies fed with breast milk and/or formula

Exclusion Criteria:

* Babies who are exclusively breastfed
* Cleft palate/lip
* Major congenital anomaly
* Intubated babies