cyrilzakka/clinical-trials huggingface dataset:
The Effects of CBD Isolate on Menstrual-Related Symptoms

The goal of this open-label clinical trial is to compared two different doses for treating menstrual-related symptoms in individuals who experience regular menstrual cycles (occurring for 4-8 days every 21-28 days). The main question it aims to answer is:

(1) if there are changes in menstrual-related symptoms from baseline compared to all 3-months of cannabidiol (CBD) isolate consumption.

Participants will complete a monthly baseline measure after they stop menstruating followed by taking CBD twice daily (BID) for five days for three menstrual cycles and complete the same measures. Researchers will compare 160mg of daily CBD isolate to 320mg of CBD isolate to see if there are differential effects on menstrual-related symptoms (MRS).


Eligibility Criteria:
Inclusion Criteria:

1. Participant is at least 18 years old.
2. Participant is willing and able to provide informed consent and participate in the study for 4 months.
3. Participant experiences a regular period (occurring every 21-38 days and lasting between 4-8 days).
4. Participant is diagnosed with Pre-menstrual Dysphoric Disorder or scores at least '30' on the Menstrual-Related Symptom Questionnaire
5. Participant is willing to begin tracking their periods and menstrual symptoms for the duration of the study
6. Participant agrees to abide by all study restrictions and comply with all study procedures.

Exclusion Criteria:

1. Participant has a known history of significant allergic condition, significant hypersensitivity to CBD, or allergic reaction to cannabis, cannabinoid medications, or excipients of the drug product.
2. Participant has been exposed to any investigational drug or device \< 30 days prior to screening or plans to take another investigational drug at any time during the study.
3. Participant has self-reported using cannabis, synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), synthetic cannabinoid receptor agonist (e.g., spice, K2), or any CBD or Tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.
4. Participant has a current or past primary Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis that the Investigator(s) determines would interfere in treatment or interfere in evaluation of the study treatment (e.g., current psychotic disorder).
5. Participant is currently prescribed medications with known THC- or CBD- interactions (e.g., warfarin, clobazam, valproic acid, phenobarbital, Mammalian target of rapamycin (mTOR) inhibitors, oral tacrolimus).
6. Participant is trying to get pregnant.
7. Participant is pregnant.
8. Participant has a history of suicide attempt in the last year.
9. Participant endorses current suicidal plan and intent during screening.
10. Any other significant disease or disorder which, in the opinion of the investigator, may either put the student at risk because of participation in the study, may influence the result of the study, or affect the student's ability to participate in the study.
11. Participant has a BMI of underweight (18 kg/m2 and below) or obese (30 kg/m2 and above).
Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening

The immediate objective of this proposal is to assess the effectiveness of a multi-faceted intervention to improve patient-provider communication about colorectal cancer screening in improving patient adherence with colorectal cancer screening recommendations. This intervention consists of: (1) guiding the communication process through patient activation to initiate a colorectal cancer screening discussion; (2) optimizing communication content through the use of a prompt sheet; and (3) cueing the provider to assess patient perception of the communication. The long-term objective of our research program is to maximize colorectal cancer screening rates throughout the VA through widespread adoption of clinically feasible approaches to enhance patient-provider communication.

In the United States, colorectal cancer is the third most common cancer and the second leading cause of cancer mortality with over 56,000 deaths in 2004). Early detection through screening decreases the mortality associated with the disease. However, adherence with current screening recommendations is low. A survey of the general population indicates that only 53.1% of Americans, age 50 years and older for whom colorectal cancer screening is recommended, are up-to-date with this preventive service. While colorectal cancer screening rates with the VA Healthcare System (VHA) are better than in the general population (75% in Fiscal Year (FY) 2005), they are lower than performance rates for other types of cancer screening (e.g., mammography) in VHA. Further, numerous VA medical centers report colorectal cancer screening rates below the level considered satisfactory.

Eligibility Criteria:
Inclusion Criteria:

Provider Eligibility:

* Primary care providers (MD, Certified Registered Nurse Practitioner (CRNP), or PA) at the study sites who see patients in the primary care setting at least 1 day per week and had no involvement in the design of the study are eligible for enrollment in the study.

Patient Eligibility:

* Primary care patients who are not "up-to-date" with colorectal cancer screening are the targeted population for study enrollment.
* Up-to-date with colorectal cancer screening is defined as having completed one of the following:

  * fecal occult blood testing within the past year
  * sigmoidoscopy within the past 5 years
  * colonoscopy within the past 10 years
  * barium enema within the past 5 years.
* Other patient eligibility criteria are:

  * Primary Care Provider (PCP) enrolled in the study
  * clinic visit scheduled with the enrolled PCP during the recruitment period
  * English speaking
  * no prior history of colorectal cancer or adenomatous polyps
  * no prior history of inflammatory bowel disease

Exclusion Criteria:

* Patients who are deemed clinically not appropriate for colorectal cancer screening due to severe comorbidity and/or limited life expectancy as determined by the patient's primary care provider will be excluded from the study.
Acoustic Neuroma: Assessing the Quality of Life by the Scale PANQOL of Patients Operated or Supervised

This study has investigated the quality of life of patients with vestibular schwannoma using this specific scale prospectively, whether treated surgically or monitored.

The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.

Three questions for this score were added, evaluating quality of life parameters that seem particularly interesting: the first regarding the difficulties in driving, the second questioning the recovery of a "normal" life, and the third assessing difficulties in working life.

The questionnaires are sent to the patient in the form of a custom web link generated on the online survey platform SurveyMonkey, and integrated into the body of an email sent from the mailbox of the investigator Hospital. There is any identifying or indirectly identifying data on the questionnaire online, guaranteeing protection of the rights of the individual. Only the principal investigator and co-investigator retain the link between the coded identity of persons undergoing research used to associate personal health data and their name (s) and name (s) (correspondence table retained securely to the paper).

Eligibility Criteria:
Inclusion Criteria:

* be in possession of an acoustic neuroma (or vestibular schwannoma) confirmed in MRI, unilateral, unoperated
* Age over 18 years
* patient insured or beneficiary of a social security scheme
* free, informed and express

Exclusion Criteria:

* History of surgery of the angle ponto-cerebellar or otologic
* Neurofibromatosis type 2
* Cons-indication to MRI
* psychiatric pathology
* Pregnant or breastfeeding women
Static and Dynamic Core Stability Exercises in Potpartum Back Pain

To compare the effects of static exercises with dynamic core stability on pain and disability in postpartum back pain.

The study comprised 28 participants. The individuals were subdivided into binary groups, group A performed static exercises and group B performed dynamic exercises including swiss ball, each containing 14 subjects. Baseline treatment (Hot pack, TENS and posture correction) to both groups was given along with core stability exercises. Core stability exercises were performed on both group for 4 weeks. The pretreatment and post treatment tests are measured using the scale VAS (visual analog scale) and Oswestry disability index questionnaire. Both groups have shown the improvement in postpartum lumber pain and an improved in daily life activities. But swiss ball exercises have more significant improvement on pain and disability in patients having postpartum lumber pain.

Eligibility Criteria:
Inclusion Criteria:

* Age groups of 18 to 35
* Pain more than 4/10 on VAS
* Without referred pain to lower limbs
* Women with normal delivery

Exclusion Criteria:

* Nulliparous women
* Osteoporosis and OA
* Systemic arterial hypertension
* Hypersensitivity to electrical modalities
* Any fracture (spine, rib) or injury
* Any abdominal surgery
* Any other general ailment
* Vertebral or disc pathologies
Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group II)


Eligibility Criteria:
Inclusion criteria

* Male or female patients with systemic lupus erythematosus (SLE)(at least 4 classification criteria)
* Aged ≥18 years,
* Proliferative lupus nephritis classified as ISN/RPS class III or IV
* Renal biopsy within the last 24-month preceding the study entry
* Proteinuria defined as \>0.5 gram urine protein per gram urine creatinine at screening and baseline
* Clinical activity defined by one or more of the following changes in renal function: Serum creatinine \>1.0 mg/dl (88.4 μmol/l)
* Microscopic hematuria defined as \>5 red cells per high power field
* Presence of cellular casts

Exclusion criteria

* Patients with calculated creatinine clearance \<30 ml/min (using the Cockcroft-Gault formula)
* Patients having received an intravenous (i.v.) corticosteroid bolus during the last 3 months,
* Patients having received oral or i.v. cyclophosphamide during the last 3 month
* Patients having received mycophenolate mofetil (MMF) within the preceding 3 months
* Use of any antibody therapy within the past 6 months
* Pregnant or nursing (lactating) women or women of child-bearing potential who are planning to become pregnant, or are not willing to use effective means of contraception throughout the study and during one month after the end of the study.
* Use of other investigational drugs within 1 month of enrollment (except for antibodies: within 6 months of enrollment
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures,
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply.
Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia

Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy.

Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic prostatectomy has not been investigated before and it is the variant that will be discussed in our study.

In laparoscopic prostatectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic prostatectomy may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Eligibility Criteria:
Inclusion Criteria:

* Pateints who will have prostatectomy ASA II or III

Exclusion Criteria: Patient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous patient controlled analgesia

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Depodur vs Fentanyl Infusion for Post-C/S Analgesia

Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women (ASA I or II) who are scheduled for an elective cesarean section
* Patient appropriate for regional anesthesia
* Patient agrees to receive regional anesthesia
* Patient willing to have an epidural infusion of medication for two days postoperatively

Exclusion Criteria:

* Morbid obesity
* History of sleep apnea
* Allergy to opioids medications
* History of opioids use during week prior to procedure
* Emergency cesarean section
* Significant surgical complications
* Contraindication or refusal to have regional anesthesia
* Age less than 18
A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults

A phase I, single dose study to test two forms of pediatric ritlecitinib compared to adult ritlecitinib in healthy adults aged 18-55 years old. Approximately 12 adults will participate for approximately 2.5 months.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete (full) physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and 12-lead ECG.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* Known immunodeficiency disorder, including positive serology for HIV at screening, or a first degree relative with a hereditary immunodeficiency
* Infection with hepatitis B or hepatitis C viruses.
* History of any lymphoproliferative disorder
* Known present or a history of malignancy other than a successfully treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
Brain Tumor Surgery and Postoperative Delirium

1. To explore whether the combined administration of dexmedetomidine during and after surgery in patients undergoing brain tumor resection is an effective and safe modality to prevent postoperative delirium and improve sleep quality than giving it alone after surgery.
2. To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can reduce postoperative acute pain and prevent chronic pain.
3. To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can provide stable anesthesia depth, hemodynamics and reduce the dose of anesthetics, thereby accelerating patient recovery.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old and less than 80 years old
* receive brain tumor surgery with ASA II\~III.

Exclusion Criteria:

* under the age of 18 or over 80
* consciousness unclear
* those who have not signed a consent form
* those with high anesthesia risk ASA IV or higher
Study, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence

This is a clinical trial phase I/II, double blind, randomized to compare in two groups of patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from the adipose tissue (CMMAd) in the treatment of the faecal incontinence.

In the phase of recruitment, of 20 months of duration, there will be included 16 participants who will be randomized to one of the groups of intervention (8 patients group CMMAd / 8 patients group placebo). The phase of follow-up of every patient will be 12 months, though, provided that these patients are seen regularly in the study sites of the study, once concluded his follow-up will be continued to be able to obtain safety information and efficacy to 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females in the age group of 18-80 yrs.
2. A unique internal sphincter defect and / or external (no more than 100 º), at any level of the anal canal, of any cause (except those described in the exclusion criteria).
3. Severity of faecal incontinence of 12 or more in the Wexner Score and / or at least six episodes of faecal incontinence for a period of 28 days.
4. Duration of faecal incontinence of at least two years prior to inclusion.
5. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent.

Exclusion Criteria:

1. More of an external sphincter defect and / or at any level of internal anal canal.
2. Have received treatment to faecal failure with bulking agents, neuromodulation or surgery.
3. Current anorectal tumors.
4. Current anal fissures.
5. Anorectal stenosis
6. Chronic pelvic or anorectal pain.
7. Pregnant or 6 months postpartum.
8. Medical history of infection with Human Immunodeficiency Virus (HIV) or any severe immunocompromised state or therapy immunosuppressive.
9. Malignancies in remission for less than a year before the study. An exception to the basocellular carcinoma (BCC) in "remission" for less than a year.
10. Bleeding diathesis or current anticoagulant therapy.
11. Chemotherapy during the 6 months preceding the study.
12. Previous radiation with evidence of radiation injury in the treated area.
13. Participation in any other clinical study during the 3 months preceding the pre-study visit.
14. Patients with other serious disorders.
15. Patients with uncontrolled inflammatory disease or taking drugs prohibited in the protocol or active perianal disease.
Diagnosis of Cow's Milk Protein Allergy

The study will assess the diagnosis of cow's milk protein allergy (CMPA) among infant and children in assiut university children hospital using skin prick test and specific serum IgE as well as their management.

Food allergy is a reproducible specific immune response to exposure to a given food. Cow's milk protein allergy (CMPA) is clinically abnormal reaction to cow's milk protein (CMP) via immune mechanisms triggered by milk protein (Boyce etal.,2010).

According to European academy for allergy and clinical immunology (EAACI) and the world allergy organization (wao) , a hypersensitivity reaction to cow's milk involving the immune system can be called as CMPA. There is difference between CMPA and non-allergic cow's milk intolerance (e.g lactose intolerance) which occurs as a result of lactase deficiency without involvement of the immune system (Venter etal.,2013).

CMPA is categorized into immunoglobulin IgE mediated , non -IgE mediated ,or mixed CMPA (Sicherer etal.,2001).

1.9% to 4.9% prevalence of CMPA among children with a peak in prevalence (2-3%) in the first year of life and prevalence of \<1% in children aged \>=6 years (koletzko etal.,2012).

Eligibility Criteria:
Inclusion Criteria:

* - Exclusively breast feeding ,breast-fed infants with supplementary foods and non-breast fed infants with supplementary foods who complain from either frequent regurgitation, vomiting,diarrhea,constipation (with/without perianal rash) ,blood in stool or pallor.

Exclusion Criteria:

* : Infant and child with gastrointestinal symptoms due to specific etiology.
A Clinical Trial Evaluating the Effectiveness and Safety of a mmWave Radar Based Sleep Respiratory Monitoring System

This study compares the diagnostic capability of a millimeter-wave radar-based Sleep Respiratory Monitoring System to the gold standard polysomnography.

The gold standard for the diagnosis of sleep breathing disorders is polysomnography (PSG), which requires contact sensors, in-lab monitoring and manual scoring by experts, limiting the comfortability of patients and accessibility of diagnosis. A novel contactless millimeter-wave radar-based Sleep Respiratory Monitoring System is developed, in order to assist sleep staging and the diagnosis of sleep breathing disorders.

The Sleep Respiratory Monitoring System is capable of collecting, recording, storing and analyzing breathing, heartbeat, spatial distribution of full-body movements, etc. via a millimeter-wave radar, and oxygen saturation, pulse, etc. via a pulse oximeter. A dedicated algorithm enables the system to detect respiratory events and estimate sleep stages based on the collected data. The device and algorithms are to be validated in this study by comparison with PSG.

Eligibility Criteria:
Inclusion Criteria:

* Participants is 18 years of age or older.
* Participants is willing to undergo overnight polysomnography and Sleep Respiratory Monitoring System testing.

Exclusion Criteria:

* Participants with severe cardiovascular and cerebrovascular diseases, severe liver, kidney, and lung dysfunction.
* Participants with unstable respiratory diseases, or other diseases in acute phase.
* Long-term or current use of barbiturates, benzodiazepines, sedatives and other drugs that may affect sleep.
* Participants that undergo CPAP treatment during the night of the trial.
* Participants with other sleep disorders, e.g. insomnia.
* Participants with mental disorders.
* Participants that refuse to sign informed consents.
* Participants unable to cooperate with medical examination.
* Participants excluded in the opinion of the investigator.