cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer

This phase 2 multicenter clinical trial assess the safety and efficacy of inhaled PPP001 to relieve the pain in 78 advanced cancer patients with uncontrolled symptoms. This is a 4-week treatment period study followed by an open label period of 1 year.

This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 on uncontrolled cancer pain in patients with symptoms related to advanced incurable cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent,
2. Adult male and female patients at least 18 years of age,
3. Subject agreed to follow the protocol,
4. Advanced cancer for which there is no known curative therapy as per investigator's judgement,
5. Patients experiencing at least 2 symptoms related to cancer \> 4 on ESAS-r-CS NRS including pain symptom,
6. Life expectancy six weeks or longer with PPS \> 50% and PaP Score Group A (30-day survival probability \>70%),
7. No cognitive impairment according to Mini-Cog©,
8. The patient is able to perform deep inhalations with FEV1 more than 60%,
9. Ability to read and respond to questions in English,
10. A female volunteer must meet one of the following criteria:

    If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose, If of non-childbearing potential - should be surgically sterile or in a menopausal state,
11. A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.
Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer

Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients will be treated with docetaxel or docetaxel-gemcitabine.

Aim of the study is to assess the optimal dosage and safety in this setting.


Eligibility Criteria:
Inclusion Criteria:

* histologically verified diagnosis of breast carcinoma, at first diagnosis
* restricted previous adjuvant chemotherapy (completed \>6 months prior the study)
* measurable and/or non-measurable disease
* previous radiotherapy is allowed if:terminated at least 10 days prior the sudy therapy, at least one target lesion for evaluation of tumor response has not been irradiated
* performance status 0-2 (WHO, Zubrod)
* adequate bone marrow reserve defined
* adequate liver / renal functions defined

Exclusion Criteria:

* any prior systematic chemotherapy for metastatic breast cancer
* expected survival time less than 12 weeks
* past or current history of malignant neoplasm other than breast carcinoma

  * except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri
* known brain metastases/leptomeningeal involvement
* active uncontrolled infection
* symptomatic peripheral neuropathy \> grade 2 according to NCI
* patients whose lesions are assessable only by radionuclide scan or patients with sclerotic bone lesions as the only site of disease
* concomitant illness that is contraindication to the use of corticosteroids
* other concomitant serious illness or medical condition, which may worsen due to the treatment
Feasibility Study to Assess the Early Use of Porcine Cross-linked Collagen Paste in Cryptoglandular Anorectal Fistulas

This study is designed to assess the effectiveness of porcine cross-linked collagen paste for the treatment of patients with ano-rectal abscess with underlying cryptoglandular fistula in ano.

Most anal fistulae are thought to arise as a result of the infection of anal glands. This infection frequently presents as an anorectal abscess which requires drainage of the abscess under a general anaesthetic. Abscess and fistula should be considered as the acute and chronic phase of the same anorectal infection.The abscess represents the acute inflammatory event, whereas the fistula is representative of the chronic process. At the time of drainage of the anorectal abscess, the underlying fistulas frequently go undetected. As a result, patients present with a fistula in ano several months later.

In this study, the investigators aim to identify the underlying fistula in patients with a perianal abscess with the help of an MRI Scan done in the acute setting. Participants with a confirmed fistula on the MRI scan have their abscess treated as per convention. However, a repeat examination under anaesthetic is performed 7-'10 days later when the fistula tract is identified and treated with injection of the porcine collagen paste into the fistula tract. Participants are followed up clinically and radiologically to assess the effectiveness of the intervention.

Eligibility Criteria:
* Inclusion Criteria:

  o Clinical diagnosis of Cryptoglandular fistula in ano.
* Exclusion Criteria:

  * Insulin dependent diabetes
  * Thyroid disease
  * Fistula secondary to Crohn's disease/Ulcerative Colitis
  * Clinical or radiological evidence of secondary tracts.
  * Complex fistula tracts on MRI scan such as Horseshoe fistula, anorectal-vaginal fistula
  * Patients refusing informed consent for admission to the study.
  * Previous fistulotomy/fistulectomy
  * Pregnancy
  * Patients unable to consent
  * Patients not suitable for MRI scan those with- Cochlear implant, Permanent pacemaker, Implanted metal work, Aneurysm clips, Claustrophobia, Metallic foreign body
Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 30-75 years old
* Body Mass Index (BMI) \<27 kg/m2

Exclusion Criteria:

* Uncontrolled hypertension
* Glomerular filtration rate less than 60 mL/min/1.73 m2
* History of recurrent gastrointestinal bleeding
* Unable or unwilling to provide informed consent
* Ongoing anti-coagulant therapy
Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?

Terminal constipation affects 13 to 20% of the french population. Anismus is defined by an absence of relaxation or a paradoxical contraction of the striated anal sphincter muscle during defecation.

Anismus is one of the main causes of terminal constipation. Anismus diagnosis is retained if 2 out of 3 examinations (manometry, electromyogram, defecography) are positive.

EndoFLIP® is a new medical device developed to measure distensibility of a hollow organ. Anal EndoFLIP® l could be a more sensitive and specific tool for detecting anismus in patients with distal constipation.

60 patients suffering from distal constipation will be included in order to perform, in addition to the usual examinations, an anal EndoFlip in order to test the sensitivity and specificity of this method for the diagnosis of anismus.


Eligibility Criteria:
Inclusion Criteria:

* patient older than 18 years
* patient with distal constipation defined according to the Rome IV criteria, for at least 3 months and verified by a transit time study showing a predominant slowing of markers at the recto-sigmoid level.
* patient who read and signed the informed consent form

Exclusion Criteria:

* Patients with a predominant right of left colonic constipation;
* Pregnant woman or woman with no effective contraception and of childbearing age
* Patient with inflammatory bowel disease, ischemic colitis, history of colon or rectal cancer, infectious colitis or proctologic disease.
* Patient with anorectal malformation
* Patient with an history of pelvic floor radiotherapy
* Patient with a digestive stoma
* Insertion of the probe impossible or painful
* Patient who has participated to a clinical trial within 30 days prior to the inclusion visit
* Patient not understanding or reading French
* Patients under guardianship, curatorship, safeguard of justice
* Patient without liberty by administrative or judicial decision
Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)

The primary objective is to demonstrate a longer period of neurologic recovery from a sensory block assessed in each test group versus the group without metabolic disease.


Eligibility Criteria:
General Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 1 month of follow up
* The patient is scheduled for hand or wrist surgery

Inclusion Criteria for the "Renal Insufficiency" group

* Patient has renal insufficiency as defined by a creatine clearance of \< 30ml/min without dialysis

Inclusion Criteria for the "Diabetes" group

* Patient has chronic hyperglycemia, either a fasting glycemia \> 1.26 g/l (7mmol/l) for longer than 5 years and receiving an oral, well-adjusted (last HBA1c \< 6.5%)), non-insulin, antidiabetic treatment

Inclusion Criteria for the "Non-exposed" group

* Patient without metabolic or neurologic disease, with creating clearance \> 90ml/min

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* Patient weighs less than 50 kg
* Score ASA \> 4
* contra indication for locoregional anesthesia
* Severe metabolic and / or decompensated renal disease, cardiac or pulmonary decompensation
* Associated peripheral neuropathy associated with diabetes or kidney disease
* Associated central neuropathy associated (eg MS ... narrow cervical canal)
* Patients with both renal failure and diabetes
A Clinical Trial to Compare the Safety, Tolerability, and PK Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216.

This is a randomized, open-label, single dose, 2-part, cross-over clinical trial to compare the safety, tolerability, and pharmacokinetic properties of DA-5216 and DA-5216-R and to evaluate the food effect on DA-5216 in healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteer 19 years to 50 years
* Body weight in the range of 50.0kg and body mass index in the range of 18 to 27kg/m2
* Subject who are negative in pregnancy test or pregnant or Lactating women
* The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
* The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire

Exclusion Criteria:

* Subject with serious active hepatobiliary, respiratory, digestive, hematologic, endocrine(diabetes mellitus, aldosteronism), immunologic, cardiovascular(hypertension, angina, heart failure, myocardial infarction, etc.), neurologic, urologic, otorhinolaryngologic, musculoskeletal, psychological disease or history of such disease
* Subject with gastrointestinal disease (Crohn's disease, peptic ulcer, acute or chronic pancreatitis, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery).
* Subject who have galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
* Subject who have had one or more of the following findings

  * AST, ALT \> 1.5 times the upper limit
  * CPK \> 2.5 times the upper limit
  * eGFR \<60mL/min/1.73m2
Maternal & Infant Morbidity and Mortality

The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health. Our hypothesis is that patients with minority status, particularly Black and Hispanic Americans, are more likely to have poor outcomes (based on various health metrics) compared to Non-Black, Non-Hispanic patients. We hypothesize further that it is likely not far off from national trends, which indicate that Black parturients are x4 more likely to die during childbirth, and Black children are 2.4x more likely to die before their first birthday than Non-Hispanic White children.

The EPIC database will be used on an institutional basis to obtain information and accessed by UVA statistician to perform the research described in this submission. The dataset does contain a few direct identifiers of medical record numbers, dates, and postal number. We anticipate that all statistical analysis will be performed at UVA by participating faculty/staff.

The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health. Our hypothesis is that patients with minority status, particularly Black and Hispanic Americans, are more likely to have poor outcomes (based on various health metrics) compared to Non-Black, Non-Hispanic patients. We hypothesize further that it is likely not far off from national trends, which indicate that Black parturients are x4 more likely to die during childbirth, and Black children are 2.4x more likely to die before their first birthday than Non-Hispanic White children.

The EPIC database will be used on an institutional basis to obtain information and accessed by UVA statistician to perform the research described in this submission. The dataset does contain a few direct identifiers of medical record numbers, dates, and postal number. We anticipate that all statistical analysis will be performed at UVA by participating faculty/staff.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* N/A
Honey Against Sore Throat

Objective: The aim of this study is to investigate the symptomatic efficacy of oral use of different functional honeys in patients complaining of sore throat.

Materials and Methods: In the preclinical phase of the study, a total of 1000 samples of honey were examined, and the honeys were subjected to physicochemical and microbiological analyses. Based on their functional properties, five different groups of honey were determined. These are thyme honey with high antioxidant capacity, Yüksekova with high antimicrobial activity, chestnut honey with high organic acid amount, linden honey with high enzymatic and pine honey with high anti-microbial, antioxidant and phenolic compounds and enzymes. In the clinical phase of the study, patients receiving conventional treatment were randomly assigned to receive either one of five different types of honey or a honey-like food product in addition to their treatment. They were instructed to use 15 grams twice daily for 10 days. Patients were assessed on the 1st, 3rd, 7th, and 10th days for symptoms and complaints such as sore throat, difficulty swallowing, sensation of throat swelling, weakness, and fatigue.


Eligibility Criteria:
Inclusion Criteria: Adults presenting with sore throat symptoms due to an upper respiratory infection (URI) within the last four days were included in the study. A total of 300 patients over 18 years of age, who were prescribed necessary medication and exhibited signs and symptoms of sore throat, were enrolled.

Exclusion Criteria: Exclusion criteria included a history of diabetes, pollen or bee allergies, and aversion to honey. Participants were required not to use any additional products outside of those provided by the researchers during the study period. Written informed consent was obtained from all participants, who were then randomly assigned to either the study or control group.
Magnifying NBI Endoscopy for Gastric Condition

Recently, the improved resolution with standard endoscopy allows the close observation of highly inflamed gastric mucosa without a magnifying view. In a previous study, the investigators established the endoscopic classification of H. pylori-infected stomach by non-magnifying standard endoscopy. One normal RAC pattern and three types of abnormal patterns were observed. Overall diagnostic accuracy for predicting H. pylori-infection was 91.6%. However, there is no comparison study predicting H. pylori-infection and precancerous gastric lesions between standard and magnifying endoscopy.

The investigators aimed to evaluate the diagnostic efficacies of non-magnifying standard endoscopy for predicting H. pylori-infection status and precancerous gastric conditions, compared to magnifying NBI endoscopy

Eligibility Criteria:
Inclusion Criteria:

* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed

Exclusion Criteria:

* Age \< 20 or \> 70 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding
Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence

1. OBJECTIVE:

   To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment.
2. METHODS:

This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value \>.05 rejects the noninferiority hypothesis of the mini-sling.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* Clinical and urodynamic diagnosis of stress urinary incontinence
* Absence of associated neurological diseases
* No clinically significant detrusor instability (ie, to determine which symptoms are proportionally more significant for patient incontinence efforts)

Exclusion Criteria:

* urodynamic changes suggesting a reduction in bladder capacity, bladder compliance or suggestive of bladder outlet obstruction
* Coagulopathies
* Pregnancy
* History of sensitivity to foreign body
* Acute Urinary Tract Infection
* Sequelae of high exposure to ionizing radiation
* Use of drugs that can result in high and / or risk of significant postoperative complications surgical risk, including any drug that interferes with blood clotting
* anesthetic contraindication to the procedure
* Vulvovaginitis: presence of vaginal discharge with laboratory proven infection
Effects of Vitamin B1 in Type 1 Diabetic Patients

The purpose of this study is to determine whether benfotiamine supplementation can reduce markers of microvascular complications in type 1 diabetic patients.

Despite intensive strategies designed to achieve good metabolic control, diabetic patients are still at a markedly increased risk of eye and kidney disease, nerve damage, limb amputation, stroke and myocardial infarction as a result of long-term hyperglycemia. It has recently been shown that supplementation with lipid soluble vitamin B1 (benfotiamine) in diabetic rats could effectively block three major biochemical pathways of hyperglycemic damage. It has also been shown that supplementation prevented the development of experimental diabetic retinopathy and nephropathy, without changes in glycemic control. However, the applicability of the above findings to humans is unknown, and the diabetic late complications in experimental animals do not in every aspect mirror the human diabetic complications.

This project will allow us to evaluate the potential of benfotiamine to reduce or prevent the further development of microvascular disease in type 1 diabetics.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes (of at least 15 years duration) as assessed by medical history.

Exclusion Criteria:

* Macroalbuminuria
* Symptomatic gastroparesis. Diabetic nephropathy with a creatinine clearance less than 60 cc/min.
* Evidence of chronic infection.
* History of any malignancy.
* Any chronic medical condition that unduly increases the risk for the potential enrollee as judged by study investigators.
* Pregnancy, breastfeeding or planned pregnancy within two years.
* Supplementation with thiamine \> 2mg per day and/or alpha-lipoic acid
* Chronic alcoholism/alcohol abuse.
Neuropathic Pain in Children: Multimodal Assessment and Diagnosis

Some children experience chronic pain that is related to damage or diseases that affect the nerves that send pain signals. This is known as neuropathic pain. This is not well understood and can be difficult to diagnose. It can often produce unusual feelings such as sensitivity of the skin to light touch. Neuropathic pain is often severe and difficult to treat, and can affect quality of life for the child and family. This study aims to better characterise the symptoms and signs, and impact of neuropathic pain in children.

The Investigators will determine whether a questionnaire to identify neuropathic pain in adults is also useful in children. This will help paediatricians and other doctors to recognise neuropathic pain and start appropriate treatment or know when to refer children to a chronic pain clinic.The Investigators will also measure the effects of neuropathic pain on mood, sleep, and quality of life (using questionnaires); identify changes in the sensitivity of the skin to touch and other sensations (using specialised sensory tests); and determine the feasibility of brain imaging for assessing changes in the brain (using magnetic resonance imaging or MRI), in children with neuropathic pain. This information will allow the investigators to measure how effective different types of treatment are, and help ensure children get the most appropriate treatment or interventions to reduce pain and effects on quality of life.

This pilot study of 10-18 year olds diagnosed with neuropathic pain will involve completion of questionnaires by the child and parent, and sensory testing in the child, after their clinic appointment. For some families, there will be an additional visit for MRI. Children will be recruited from the Chronic Pain Outpatients service at Great Ormond Street Hospital NHS Trust. This research is funded by Great Ormond Street Hospital Children's Charity.

Eligibility Criteria:
Inclusion Criteria:

* children with a clinical diagnosis of chronic neuropathic pain for the full protocol
* children with a clinical diagnosis of non-neuropathic origin for S-LANSS validation and questionnaires
* children aged 10-18 years

Exclusion Criteria:

* significant impairment of comprehension (less than school level for 10 year old) that will limit understanding of sensory testing instructions
* inadequate english language skills as questionnaires are validated in English and sensory testing instructions can only be delivered by the Investigators in English For brain imaging, patients will be excluded if they have
* significant medical illness or other (non-neuropathic) neurological disease
* pregnancy
* magnetic implants of any type.