cyrilzakka/clinical-trials huggingface dataset:
Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers

This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between filgrastim formulation, produced by Megalabs (test product) and Granulokine® (reference product) Amgen.


Eligibility Criteria:
Inclusion Criteria:

* Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP)
* Males aged between 18 and 55 years
* Be characterized as a healthy research participant, based on medical history general physical examination and vital signs, laboratory tests and electrocardiogram (ECG),
* Not indicating any evidence of disease
* Body weight between 60-100 kg
* Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 Kg / m2
* Negative test for coronavirus

Exclusion Criteria:

* Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8 ° C), cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospitalization period (all periods)
* Direct and significant medical contact with people who tested positive for coronavirus testing within 14 days prior to the hospitalization period (all periods)
* Living in the same household as people who are in the risk group with the worst prognosis for coronavirus infection, such as individuals over 60, individuals with respiratory problems, immunosuppressed or those with chronic diseases, such as heart or diabetes (all periods)
* Participants diagnosed with malignant disease in the last 5 years, with the exception of successfully treated basal cell carcinoma
* Participants with a previous diagnosis of severe asthma, sickle cell anemia, idiopathic urticaria or anaphylaxis
* Participants with chronic diseases and, therefore, who regularly use medications
* Being a smoker or quitting less than 6 months ago
* Participants who consume more than 5 cups of tea or coffee a day and who cannot - abstain during the trial period
* History of alcohol and illicit drug abuse
* Electrocardiogram (ECG) findings that, at the investigator's discretion, may compromise participation in the trial
* History or presence of gastrointestinal or liver diseases or any other condition that interferes with the absorption, distribution, excretion or metabolism of the drug
* Use of lithium 2 weeks before and / or after medication administration
* Participants who are hypersensitive or contraindicated to use any of the components of the formulation
* Research participants who have participated in clinical trial protocols in the last 12 (twelve) months (Resolution CNS 251, of August 7, 1997, item III, subitem J)
* Have donated blood (\> 500 mL) or have undergone major surgery in the 3 (three) months preceding the date of signing the informed consent form
* Have received any vaccine in the 3 (three) months preceding the date of signing the informed consent form
Single-Anastomosis Plication Ileal Bypass for Morbid Obesity

The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.

The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both genders aging between 18 and 60 years with morbid obesity will be included to the study

Exclusion Criteria:

* Patients with secondary obesity due to endocrine disorders
* patient unfit for general anesthesia.
* patients who had not attempted non-surgical weight loss treatment in the past
* patients with psychological conditions that influence his/her perception of the study protocol
* patients with previous surgery for morbid obesity
Open Trial of Family-Based Treatment for Anorexia Nervosa

This trial seeks to investigate the feasibility and effectiveness of delivering a newly manualized family-based treatment for adolescents with anorexia nervosa

This open trial seeks to investigate the feasibility and effectiveness of delivering a newly manualized family-based treatment for adolescents with anorexia nervosa at a site beyond the treatment's origin. Adolescents ages 12-17 with anorexia nervosa or subthreshold anorexia nervosa were treated with up to one year of this approach.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-17
* Diagnosis of full or subthreshold anorexia nervosa
* At least one parent or guardian willing to participate in treatment

Exclusion Criteria:

* Bipolar Disorder, Psychotic Disorder, Substance Dependence
* Mental Retardation
* Acute suicidal risk
* Acute or unstable, poorly controlled chronic medical illness
* Weight below 75% ideal body weight
Cognitive Processing Therapy in Syrian Women Exposed to IPV

This study aims to explore the efficacy of cognitive processing therapy (CPT) in treating depression, anxiety, PTSD, and difficulties with emotion regulation in Syrian females who have suffered intimate partner violence (IPV). Clinicians will conduct interviews with women and request that they complete the CAPS, Beck Depression Inventory II, Beck Anxiety Inventory, and DERS during pretreatment, posttreatment, and at the 12-month follow-up

This study aims to explore the efficacy of cognitive processing therapy (CPT) in treating depression, anxiety, PTSD, and difficulties with emotion regulation in Syrian females who have suffered intimate partner violence (IPV). Clinicians will conduct interviews with women and request that they complete the CAPS, Beck Depression Inventory II, Beck Anxiety Inventory, and DERS during pretreatment, posttreatment, and at the 12-month follow-up. Cognitive processing therapy (CPT) may have a substantial therapeutic benefit in the treatment of depression, anxiety, PTSD, and difficulties in emotion regulation among Syrian females who have suffered intimate partner violence.

Eligibility Criteria:
Inclusion Criteria:

* being a Syrian female who currently exposes to intimate partner violence,
* lives in Egypt
* has a good knowledge of English language because all assessments and therapy materials are in English.

Exclusion Criteria: having:

* cognitive difficulties
* schizophrenia (or any other psychotic disorders).
Study of NGM313 in Obese Participants

The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 30-43 kg/m2
* Waist circumference \> 40 inches in males or \> 30 inches in females
* Normal ECG readings

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of any known Congestive heart failure (CHF)
* History of macrovascular disease
Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam

This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. Patients will be randomized to one of two groups by block randomization.


Eligibility Criteria:
Inclusion Criteria:

* children from ages 4 years to 8 years old undergoing outpatient surgery
* children identified as needing premedication
* ASA physical status I, II or III
* planned inhalational induction
* children presenting from home prior to surgery (not an inpatient)
* English speaking parents and child

Exclusion Criteria:

* children with developmental delay
* children with psychological / emotional disorders
* children with altered mental status
* children in whom midazolam may be medically contraindicated per the discretion of the anesthesia care team
* children with language barrier
* children who are not accompanied by someone able to consent (ie legal guardian)
* children who are inpatient prior to surgery
* children with expected difficult intubation/airway
* children presenting for emergency surgery
* family history or personal history of malignant hyperthermia / risk of MH
* consent not obtained or withdrawal of consent
* children with past history of violent behaviors during induction of anesthesia
* cancellation of surgery
* patients with a diagnosis of COVID-19 or a patient under investigation for COVID-19, including patients being treated with airborne precautions in the operating room
* receipt of any type of medical sedative prior to induction of anesthesia, including (but not limited to) ketamine, and/or dexmedetomidine.
A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough

This is a multi-center, randomized, double-blind, placebo-controlled, crossover, dose escalation study of BLU-5937 in subjects with unexplained or refractory chronic cough

This study will have two 16-day treatment periods (four escalating doses or matching placebo at four days interval) separated by a 10 to 14-day washout period. There will be a 14-day follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Unexplained or refractory chronic cough for at least one year
* Chest radiograph or CT thorax within the last 60 months not demonstrating any abnormality considered to be significantly contributing to the chronic cough
* Cough count of ≥ 10 per hour (Awake Cough Count) at Screening
* Score of ≥ 40mm on the Cough Severity VAS at Screening
* Women of child-bearing potential must have a negative serum pregnancy test at Screening
* Women of child-bearing potential must use a highly effective contraception method from Screening through the Follow-Up Visit
* Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control

Exclusion Criteria:

* Current smoker or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history
* Diagnosis of COPD, bronchiectasis, idiopathic pulmonary fibrosis
* Treatment with an ACE-inhibitor as the potential cause of a subject's cough, or requiring treatment with an ACE-inhibitor during the study, or within 12 weeks prior to the Screening Visit
* FEV1/FVC \< 60%
* History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
* History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening
* History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years
* Clinically significant abnormal electrocardiogram (ECG) or laboratory tests at Screening
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results
Prayer in Commbate to Corona Virus - Covid -19

PATIENTS WHO ARE ADMITTED TO HOSPITALIZATION IN HCOR AND WHO HAVE THE CONFIRMED DIAGNOSIS OF CORONA VIRUS, WILL BE ASKED TO CONSENT TO PARTICIPATE IN THIS STUDY THAT INTENDS TO STUDY THE EFFECTIVENESS OF THE REMOTE INTERCESSION PRAYER IN COMBATING THIS DISEASE.

PATIENTS WHO AGREE TO PARTICIPATE IN THE STUDY WILL BE SEPARATED INTO 2 GROUPS, THE INTERVENTION GROUP AND THE CONTROL GROUP.

THE IDENTITY OF THE PATIENTS WILL BE KEPT IN SECRET AND ONLY THEIR INITIALS WILL BE LISTED.

THE INTERVENTION GROUP WILL RECEIVE DAILY PRAYERS AND THE EVOLUTIONARY CLINICAL RESULTS OF THE TWO GROUPS WILL BE PURCHASED.

Eligibility Criteria:
Inclusion Criteria:

Patients hospitalized in comun hospital rooms and intensive care units with confirmed COVID-19.

Exclusion Criteria:

* Patients admitted to the HCor emergency room, diagnosed with COVID-19 infection, however, without indication for hospitalization
* Patients admitted to the HCor emergency room, diagnosed with COVID-19 infection, however, without indication for hospitalization.
* Patients 18 years of age or older
* Patients with indication of palliative care and definition of terminality at hospital admission
* Patients who voluntarily choose not to participate in the study at the time of the • presentation of the Informed Consent Form.
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration

During the typical SCS trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement

Spinal Cord stimulator trials require precise placement of leads to get appropriate distribution of pain.1 Since the leads are not anchored into the tissue, migration of the leads can occur and result in suboptimal trial. Migration (or movement in the epidural space after placement) of the leads can result in up to 2.49 mm to 3.24 mm migration in the leads depending on trial length . During the trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement

Eligibility Criteria:
Inclusion Criteria:

* age greater than 18
* having a spinal cord stimulator trial lead placement done
* lead placement to be done in the thoracic spine area

Exclusion Criteria:

* dermabond allergy
* inability to place 2 leads in subject
* lead placement not in thoracic spine
Dietary Assessment in Rwanda - Food Frequency Questionnaire

The burden of non-communicable diseases (NCDs) in Rwanda is adding to the health burden in the country which is facing the nutritional transition and the double burden of malnutrition. Diet is an established risk factor in NCDs, hence the importance to assess accurately the changes in dietary habits occurring in the population. The objective is to develop and validate a food frequency questionnaire in Rwanda.

In many developing countries, including Rwanda, the lack of developed and validated questionnaires is among major challenges for dietary assessment in nutritional surveys. Questionnaires are mostly borrowed from other communities. This can increase the error range due to low adaptation to local context, especially when they are not validated and may not have similar objectives. One Food Frequency Questionnaire (FFQ) does not capture dietary history in two different countries or regions, unless their diets are similar. Besides, the diet changes with time, where new foods are introduced in diet and others may disappear. In Rwanda, one FFQ has been developed to cover only the eastern part of the country, but none for the entire country (Cade et al., 2001; FAO, 2018). It is then very important to develop and validate an update and general FFQ that can be used across the country to measure the dietary intake to have a better interpretation of the study findings from the Rwandan context.

The overall objective is to develop and validate a semi-quantitative FFQ that can be used to assess the food and nutrient intake in urban and rural communities of Rwanda.

Specific objectives include:

1. To collect data on diet intake of selected participants by using a 24-H recall questionnaire that includes pictures on the approximate quantities consumed in each occasion.
2. To develop a list of food items from commonly consumed food by study participants using the compiled 24-h recall questionnaire to use for an FFQ development. Additionally, an open question format to collect information on foods consumed during social gathering and festivals will be used to include unreported foods. FFQ shall include additionally the food portion size, and the frequency of intake over a reference period of one year.
3. To assess the accuracy of the developed FFQ in estimating energy and nutrient intake using the 24-H dietary recall as a benchmark of accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Permanent residence of the selected urban or rural villages
* Holding a valid health insurance card
* Aged between 18 and 49 years
* Signing informed consent form
* Familiar with the diet and cooking practices
* Registration in city demographic system, since study participants will be selected from population registration cards at village level,
* Accept enumerators for home visit and data collection for one year

Exclusion Criteria:

* Mental disorders such as clinically diagnosed depression, anxiety disorders, eating disorders and addictive behaviors
The Effect Of I-Gel And Ambu Aura-I Use On Laryngofaryngeal Mucosa

Supraglottic airway devices (SGADs) are frequently preferred in surgical surgery for pediatric patients. i-gel LMA (laryngeal mask airway) and Ambu Aura-i LMA are the new generation supraglottic airway devices. The aim of this study was to compare airway trauma and postoperative complications due to i-gel and Ambu Aura in infants. In the study patients were divided into two groups performed on minor surgery ASA I (American Society of Anesthesiologists score) and 40 infants. After standard anesthesia i-Gel was placed into a group and Ambu Aura-i was placed to the other. Flexible bronchoscopy was performed at the end of surgery. Mucosal damage and postoperative complications in laryngopharyngeal structures were compared.

This study was conducted as prospective, randomized and double-blind study. After confirmation the approval from the Interventional Ethics Committee of the Bezmialem Vakif University, dated.... Number...., the study was started. Forty ASA I patients under the age of 1, with a body weight of more than 10 kg, without anatomical pathology in the upper airway with no general anesthesia within the last 2 weeks who underwent minor surgery (circumcision, inguinal hernia, undescended testis, hypospadias, etc.) by the Pediatric Surgery Clinic at Bezmialem Vakif University Medical School Hospital were included in the study. Patients who are older than 1 year of age and have a body weight of more than 10 kg, who have symptoms of upper or lower respiratory tract infection, who have more than one trial performed during the SADs placement, who are known and expected to be difficult airway, who has undergone surgery for more than 2 hours and patients who underwent emergency surgery were not included in the study.

Eligibility Criteria:
Inclusion Criteria:

1. ASA I
2. patients under the age of 1,
3. body weight of less than 10 kg
4. without anatomical pathology in the upper airway
5. no general anesthesia within the last 2 weeks who underwent minor surgery

Exclusion Criteria:

1. older than 1 year of age
2. body weight of more than 10 kg
3. symptoms of upper or lower respiratory tract infection
4. more than one trial performed during the SADs placement
5. known and expected to be difficult airway
6. undergone surgery for more than 2 hours and patients
7. underwent emergency surgery
Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1)Pneumonia: Multi-centre, Prospective, Randomized Controlled Study

The purpose of the study is to determine whether the combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.

The antiviral agent, oseltamivir, is recommended by the World Health Organization (WHO) to treat recent outbreak novel influenza A (H1N1) virus infection around world. But limited stock and resistant strain emergence raised increasing concerns. Chinese medicinal herbs, are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. The investigators performed RCT to indicate that a combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed novel influenza A(H1N1) case with laboratory evidence
* 70 ys ≥ age ≥14ys
* Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom)
* New lung infiltration showed by chest radiology(x-ray or CT)

Exclusion Criteria:

* Age\<14ys or \>70ys
* Pregnancy
* Severe chronic underlying diseases: severe COPD(FEV1/EVC \<70% and FEV1 \<30% predicted or respiratory failure or congestive heart failure), severe liver disfunction（ALT or AST ≥3 times normal elevation), renal disfunction（Cr\>2mg/dL), chronic heart failure(NYHA Ⅲ-Ⅳ grade）
* Immunocompromised patients(cancer, organ transplant, AIDS and a history of treatment with immunosuppressive drug and glucocorticoids in the past 3 months)
* Taken Chinese medicinal herbs, antiviral or antibiotic drug in the past 2 weeks
* Inoculation influenza vaccination
* One of the following items appeared at the enrollment

  * respiratory failure：PaO2\<60mmHg and/or PCO2\>50mmHg or PaO2/FiO2≤300
  * circulation failure: despite adequate fluid resuscitation and cardiac output, systolic \<90mmHg or requirement inotropic support
  * renal function failure: despite adequate fluid resuscitation and cardiac output, urine ≤ 0.5ml/kg.h, Cr or BUN≥1 time normal elevation
  * liver function failure: total bilirubin\>34μmol/L or ALT/AST ≥3 times normal elevation
* Other unappropriated enrollment situations considered by investigator