cyrilzakka/clinical-trials huggingface dataset:
A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis

To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral mucositis in patients receiving conditioning treatment for hematopoietic stem cell transplantation (HSCT). The primary variable will be the area under the curve (AUC) of oral mucositis scores defined by the World Health Organisation (WHO) oral toxicity scale assessed daily by the investigator over the 28-day study period.

This was multicentre, open-label, randomised parallel-group study. Patients were randomised to one of two parallel treatment groups: episil® in combination with SOC or SOC alone.

The study was originally planned to be conducted in several sites in the following countries: Denmark, Israel, Poland, and Sweden. Following a country-specific Amendment on 20-Feb-2013 and a German Ethical Committee (EC) approval in 07-May-2013, Germany was added to the list of countries where the study would be conducted. No study sites were initiated in Denmark.

The study design was aimed to facilitate direct comparison of the performance of SOC + episil® versus SOC alone. The study was conducted in an open-label manner that is common in trials involving cancer patients, as this takes into the account the ethical issues involved in this indication and patient population. To reduce the likelihood of bias, assignment to study treatment was randomised.

SOC as control group is appropriate and widely used, especially in trials involving cancer patients. In this particular study, basic oral hygiene consisting of brushing, flossing, rinsing and moisturising was taken as the SOC used as control group.

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Eligibility Criteria:
Inclusion Criteria:

1. Is at least 18 years of age.
2. Has a confirmed diagnosis for which he/she is scheduled for hematopoietic stem cell transplantation (HSCT) of either type of transplant (autologous or allogeneic).
3. Is due to undergo treatment with myeloablative conditioning (radiation-based or non radiation based) before HSCT.

Exclusion Criteria:

1. Will undergo reduced intensity conditioning before HSCT.
2. Has got known allergy to any ingredient in the study product or to peanuts, peppermint oil, or soya.
3. Is pregnant or breast feeding.
4. Has any other concurrent medical condition that, in the opinion of the investigator, would increase the risk to the patient, compromise evaluation of the investigational device, or interfere with the conduct of the study.
5. Has an unstable condition (eg, a psychiatric disorder, a recent history of substance abuse) or is otherwise thought to be unreliable or incapable of complying with the study requirements.
6. Is undergoing treatment with parenteral opioids at enrolment.
7. Uses treatments that promote mucosal healing (eg, palifermin).
8. Uses electrolyte mouthwashes (eg, Caphosol®) or other topical oral treatments (eg, Tantum Verde® (benzydamine), Gelclair®, Fungicidin (nystatin)).
A Clinical Study to Evaluate the Use of a Cryopreserved Formulation of OTL-103 in Subjects With Wiskott-Aldrich Syndrome

This is an open-label, single arm study to evaluate the cryopreserved formulation of OTL-103 Gene Therapy. OTL-103 consists of autologous CD34+ hematopoietic stem cells in which the gene encoding for the Wiskott-Aldrich Syndrome is introduced by means of a third generation lentiviral vector.


Eligibility Criteria:
Inclusion Criteria:

* Age: up to 65 years
* Diagnosis of WAS defined by genetic mutation and at least one of the following criteria:

  * Severe Wiskott-Aldrich Syndrome (WAS) gene mutation, defined by literature data (genotype/phenotype studies).;
  * Absent WASP expression, assessed by flow cytometry;
  * Severe clinical score (Zhu clinical score ≥ 3);
* No human leukocyte antigen (HLA)-identical related donor available for hematopoietic stem cells transplant (HSCT).

Exclusion Criteria:

* End-organ dysfunction, severe active infection not responsive to treatment or other severe disease or clinical condition which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
* Malignant neoplasia (except local skin cancer) or a documented history of hereditary cancer syndrome.
* Myelodysplasia, cytogenetic alterations characteristic of myelodysplastic syndrome and acute myeloid leukaemia , or other serious haematological disorders
* Documented human immunodeficiency virus (HIV) infection
* Prior allogeneic hematopoietic stem cell transplantation, with evidence of residual cells of donor origin
* Symptomatic herpes zoster, not responsive to specific treatment
* Evidence of acute tuberculosis
* Acute or chronic stable Hepatitis B
* Presence of positive Hepatitis C RNA test result at screening
* Patients not eligible for mobilization protocols in order to obtain CD34+ cells
* Previous Gene Therapy
Effects of Long-term Exercise on Various Parameters in Heavy Drinkers

The purpose of this research is to examine the effects of long-term aerobic exercise of moderate intensity on psychological, physiological, biochemical, physiological and alcohol-related parameters in heavy drinkers, in order to investigate possible biochemical mechanisms by which exercise may be a healthy alternative to alcohol abuse.

The mechanism of incentives that lead people to unhealthy habits such as excessive alcohol consumption is not only social, personal, and psychological, but also associated with neurochemical and neurobiological mechanisms.

Several programs have been developed to stop excessive drinking, but the success rates are small, while the relapse rates are very high, reaching up to 90%. Although there is some evidence for the beneficial effects of exercise on alcohol use disorders, research is limited. The present study investigates whether exercise can act as adjunct therapy for alcohol abuse cessation.

One of the basic assumptions is that the appropriate form of exercise in alcoholics will contribute to the secretion of beta-endorphin, which in combination with psychological pleasure, vitality, change of mood, reduced stress, increased confidence, and the shift of attention will help people to follow healthy lifestyles and abhor alcohol.

The research project is divided in three phases. In the first phase, the effect of acute exercise in critical psychological, physiological, biochemical and alcohol-related parameters associated with excessive alcohol consumption will be examined. In the second phase (current study), a long-term exercise program in conjunction with psychological support strategies aimed at alcohol abuse cessation will be developed, implemented and evaluated. Finally, in the third phase, based on the results of the previous phases, awareness programs in adolescent and adult populations will be designed and implemented as well as the dissemination of results and evaluation of the project will take place.

Eligibility Criteria:
Inclusion Criteria:

* Men drinking \>14 drinks/week or \>4 drinks/occasion; Women drinking \>7 drinks/week or \>4 drinks/occasion (1 drink = 14 grams of pure alcohol; definition of the NIAAA for drinking at low risk for developing an AUD; NIAAA, 2014)
* Individuals drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days (1 drink = 14 grams of pure alcohol; definition of the Substance Abuse and Mental Health Services Administration for heavy drinking; NIAAA, 2014) Alcohol Use Disorders Identification Test (AUDIT) score\>8

Exclusion Criteria:

* Medical conditions or medication use that would preclude participation in aerobic exercise
Strategies for Enhancing Mucosal Immunity to Influenza Vaccine

The purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). The investigators will measure the systemic (through out the body) and mucosal immune responses (how your body recognizes and defends itself against bacteria) to nasally administered influenza vaccine, and determine if nasal immunization results in immunity (your body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral and reproductive), in comparison with intramuscular administration and placebo (inactive substance given in the same form as the active drug).


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women ages 18-50 years
* Non-smokers (defined as no tobacco use within the last 12 months and less than 10 pack-year lifetime tobacco use)
* Willing and able to provide written informed consent
* Able to speak and understand English
* Women of childbearing potential must have a negative serum pregnancy test.

Exclusion Criteria:

* Influenza vaccination within 6 months prior to screening date
* Symptoms of respiratory infection during the 14 days prior to screening
* Temperature \>38.3o C during the period spanning 72 hours prior to screening and the time of immunization.
* History of allergy to egg, influenza vaccine or vaccine ingredients
* History of Guillain-Barre syndrome
* History of Bell's palsy
* Tonsillectomy, adenoidectomy or prior surgery to the paranasal sinus cavity.
* Physician diagnosis of or personal history of allergic or chronic rhinitis
* Physician diagnosis of or personal history of asthma
* Acute sinusitis within 30 days prior to screening
* Use of antibiotics within 14 days prior to screening
* Requirement for use of nasal corticosteroids for the period beginning 30 days prior to screening through final study visit
* Requirement for use of antihistamines (systemic, intranasal or intraocular) for the period beginning 72 hours prior to screening through final study visit
* Use of immunomodulating drugs or systemic corticosteroids within 6 months prior to screening (includes but is not limited to azathioprine, methotrexate, mycophenolate mofetil, tumor necrosis factor inhibitors, cyclosporine, tacrolimus)
* Past or present history of allergen immunotherapy to within the last 10 years.
* Students or employees who are under direct supervision by any of the investigators in this protocol are not eligible to participate.
* Subjects who abuse alcohol or illicit substances will be excluded.
* Other medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements.
* Nursing mothers.
* Other investigational medication use within 30 days of screening.
Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause

This is a 8-week, double-blinded, placebo-controlled, randomized intervention trial to investigate the effects of Mg and Zn supplementation on antioxidant status and bone hormonal parameters. Participants were randomly assigned to one of three treatment groups: Placebo group (PbG: 25 women); Magnesium Group - 500 mg/day of Mg (MgG: 27 women); Zinc Group - 50 mg/day of Zn (ZnG: 26 women).

Seventy-eight healthy postmenopausal volunteers aged between 44 and 76 were recruited once had been informed about the protocol. This is a 8-week, double-blinded, placebo-controlled, randomized intervention trial to investigate the effects of Mg and Zn supplementation on antioxidant status and bone hormonal parameters. Participants were randomly assigned to one of three treatment groups: Placebo group (PbG: 25 women); Magnesium Group - 500 mg/day of Mg (MgG: 27 women); Zinc Group - 50 mg/day of Zn (ZnG: 26 women).

Eligibility Criteria:
Inclusion Criteria:

* to present postmenopausal status (with at least 12 months of amenorrhea)
* to present low status in Mg and/or Zn obtained in a previous biochemical assessment
* not present any pathology that could affect their nutritional status
* not to be subjected to hormone replacement therapy (HRT)
* not to demonstrate lactose intolerance

Exclusion criteria

* acute or terminal illness
* unwillingness to either complete the study requirements or to be randomised into control or experimental group
* to be smoker
* to be on a medication regimen
Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection

The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.

Adjuvant Radiotherapy(Postoperative radiotherapy) is proposed in stage II and III thymic carcinoma，stage III thymoma，stage IIB B2/B3 thymomas.

Hypofractionation Radiotherapy is used in this study. The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.

Eligibility Criteria:
Inclusion Criteria:

* Thymoma and Thymic carcinoma confirmed by histology or cytology
* R0 resection (complete resection)
* stage II and III thymic carcinoma，stage III thymoma，stage IIB B2/B3 thymomas.
* Karnofsky performance status(KPS) 80, 90 or 100.
* Having sufficient Pulmonary function, renal function and liver function. Neutrophile granulocyte count\>1.5×109 /L, platelet count\>80×109 /L, hemoglobin ≥10g/dL.

Exclusion Criteria:

* Prior thoracic radiotherapy.
* Uncontrolled Comorbidities.
* Pregnant or nursing mother.
* Pneumonia
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.

Objective:

To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fed Conditions.

Study Design:

An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

* Volunteers must meet all of the following criteria in order to be included in the study:

  1. Sex: male.
  2. Age: 18 - 45 years.
  3. Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
  4. Healthy and willing to participate in the study.
  5. Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
  6. Non-smokers or smoker who smokes less than 10 cigarettes a day.

Exclusion Criteria:

* The volunteers will be excluded from the study based on the following criteria:

  1. Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  2. Clinically significant abnormal ECG or Chest X-ray.
  3. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  4. Pulse rate less than 50/minute or more than 100/minute.
  5. Oral temperature less than 95°F or more than 98.6°F.
  6. Respiratory rate less than 12/minute or more than 20/minute
  7. Addiction to alcohol or history of any drug abuse within the past 2 years.
  8. Recent History of kidney or liver dysfunction.
  9. History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  10. Administration/ Intake of prescription or OTC medication for two weeks before the study.
  11. Patients suffering from any chronic illness such as arthritis, asthma etc.
  12. HIV, HCV, HBsAg positive volunteers.
  13. Opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, Cocaine positive volunteers based on urine test.
  14. Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
  15. Administration of any investigational products in the period 0 to 3 months before entry to the study.
  16. Intake of barbiturates or any enzyme-inducing drug in last three months.
  17. History of significant blood loss due to any reason, including blood donation in the past 12 weeks. The total blood loss in last 3 months including for this study will not exceed 350ml.
  18. Existence of any surgical or medical condition, which, in the judgement of the Chief Investigator and/or clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
  19. Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Selective Dose Escalation for Esophageal Cancer

This prospective study was designed to assess the outcomes (survival and failure patterns) of therapy for localized esophageal cancer with conventional dose radiation (RT; 50.4 Gy) with concurrent continuous infusion 5-fluorouracil (5-FU) and weekly carboplatin/paclitaxel. Patients with less than complete response (CR) or partial response (PR) received dose escalation of radiation to 59.4 Gy with the same chemotherapy.

we prospectively enrolled patients with T1-4, N0-1, M0-1a esophageal carcinoma to receive paclitaxel 45 mg/m2 IV over 1 hour and carboplatin AUC 2 IV over 30 minutes on days 1, 8, 15, 22, 29 and 36. 5-FU 225mg/m2 was delivered as a continuous infusion on days 1-38. RT was given 1.8Gy 5 days/wk for 5.5 wks (50.4Gy in 28 fx). After 6-8 weeks, patients underwent repeat staging with computed tomography (CT) scan, endoscopic ultrasound (EUS), and biopsy. Patients with a positive biopsy, or less than PR by CT and EUS, received a boost of 9 Gy with the same concurrent chemotherapy. Patients were followed every 4 months with CT/EUS first year, every 6 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* T1-4, N0-1, M0-1a esophageal carcinoma

Exclusion Criteria:

* distant metastases
Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN)

Phase II clinical trial

The aim of this trial is to compare the degree of efficacy, safety and tolerability of CG 428 cutaneous solution versus placebo on prevention of chemotherapy induced alopecia (CIA) in female patients with metastatic cancer treated with selected regimens inducing alopecia.

Eligibility Criteria:
Inclusion Criteria:

* Adult female, age ≥ 18 years.
* Patient with cancer, requiring one of the following pre-specified chemotherapy regimen according to local guidelines: weekly paclitaxel, weekly docetaxel, eribuline or associationof weekly paclitaxel/docetaxel with carboplatine (association of targeted therapies not influencing significantly the risk of alopecia is allowed, i.e. trastuzumab, pertuzumab or bevacizumab).
* Healthy hair (no current alopecia or scalp disease treatment).
* Life expectancy ≥ 6 months.
* Able to use the study treatment in compliance with the protocol.
* Physical and psychological ability to participate.
* Negative serum pregnancy test within 14 days prior to randomization in premenopausal women with childbearing potential.
* Patients must agree to not shave their head (minimum ≥ 1 cm).
* Signed and dated informed consent.

Exclusion Criteria:

* Other ongoing anti-neoplastic therapy or other investigational drug with potential effect on hair growth.
* Patients treated with proteasome inhibitors, i.e. bortezomib.
* Prior radiotherapy to the scalp with residual alopecia.
* Known allergy or hypersensitivity to some components of CG 428 cutaneous solution (including allium cepa (onion), citrus, caffeine, theobromine).
* Pre-existing alopecia or significant scalp disease, which may alter study treatment administration or absorption.
* Concomitant use of cold cap or any other anti-hair loss treatment.
* Hair transplants.
Using mHealth Technology to Identify and Refer Surgical Site Infections in Rwanda

The present study aims to examine whether or not the use of mobile Health (mHealth) by community health workers (CHWs) can improve the identification of surgical site infection (SSI) and a timely return to care among patients who undergo cesarean-section surgery at a rural hospital in Rwanda.

Surgical site infections (SSI) are a significant cause of morbidity and mortality worldwide, and particularly in low- and middle-income countries, where geographic and infrastructural barriers often delay or prevent post-operative patients from returning to care. In these settings, rates of SSI can reach 30%. In Rwanda, the current standard of care does not include follow-up of post-operative surgical patients. There, a network of community health workers (CHWs) is employed to provide care and follow-up for pregnant and post-partum women as well as children under five years of age. However, the limited education and existing work load of these workers preclude them from supporting the follow-up of other specialized conditions, such as post-operative patients.

The interventions evaluated in this proposed research seeks to address these gaps. The main aim is to evaluate the impact of the SSI screening protocol, delivered by sCHWs equipped with mHealth support, on the rate of return to care for patients with SSI 10 days post-operation. Two CHW-mHealth interventions will be evaluated. In the first, a sCHW will visit post-operative study participants in their homes to administer the screening protocol prompted by the mobile phone. In the second, a sCHW will call the patient and administer the same screening protocol over the phone. In this phase of the research, 364 patients will be assigned to each of these delivery arms, and the rates of appropriate return to care will be compared to that of 364 patients in a control arm receiving the standard of care (i.e. no additional follow-up). Process indicators also will be reported to describe the feasibility of CHW-mHealth interventions.

Investigators believe that the SSI screening protocol administered via CHW-mHealth interventions can support accurate diagnosis of SSI and refer patients back to the hospital for appropriate follow-up care. The research team's close collaboration with colleagues at the Rwanda Ministry of Health will facilitate the scale-up of the intervention, should it prove efficacious. Results of this study will also inform the development of similar mHealth interventions across other disease areas, allowing CHWs to expand services to other specialized patients in rural African settings.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients that have undergone cesarean-section surgery at Kirehe District Hospital

Exclusion Criteria:

* Patients from Mahama Refugee Camp will not be asked to participate in follow-up activities due to travel autonomy issues
* Patients that are not residents of Kirehe District
* Patients that have surgery other than cesarean delivery
* Patients that have not been discharged by 7 post-operative days (POD)
Differential Effects of Zolpidem Versus Ramelteon in Burned Children

To examine sleep changes following therapeutic drug interventions designed to promote sleep.


Eligibility Criteria:
Inclusion Criteria:

* Burn injury \> 20% total body surface area
* Between 3 and 18 years of age
* \< 7 days from acute injury
* Written informed consent and HIPPA release signed

Exclusion Criteria:

* Suspected anoxic brain injury or head injury
* Hepatic or endocrine disease
* History of alcoholism or substance abuse
* Pre-existing neurological or primary psychiatric disorder
* Medical history of pre-existing sleep disorder or lactose deficiency
* Questionable survival (\<72 hrs) as decided by PI
* Receipt of drugs with known effects on sleep within 24 hrs of study entry
* No informed consent/HIPPA release