cyrilzakka/clinical-trials huggingface dataset:
Quantification of Transition Metals

In this trial, concentrations of transition metals of interest are quantified in surplus cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals will be performed by inductively coupled plasma mass spectrometry (ICP-MS). The treating physicians as well as the patients will not be informed about the results of drug concentrations.

Samples used include:

Remaining portions of samples collected for diagnostic or therapeutic reasons (paired CSF and blood serum samples). No lumbar puncture will be done specifically for this protocol.

The objective of this study is to gain an overview about transition metals concentrations in blood serum and CSF in order to provide preliminary data on patients. The effect of neurodegenerative diseases on metals or the other way round will be assessed if possible.

Eligibility Criteria:
Inclusion Criteria: •

* The trial will include any patient (with various diseases, especially neurodegenerative diseases) who received a lumbar puncture.

Exclusion Criteria:

* • The lower age limit is 18 years. In concordance with the objective of the project there is no specific exclusion criteria.
Survival Outcomes of Ovarian Malignancies in Chinese Population

This study aims to determine survival outcomes (overall survival and progression-free survival) of primary ovarian malignancies in China and relevant risk factors in a prospective cohort study.


Eligibility Criteria:
Inclusion Criteria:

* Primary ovarian malignancies.

Exclusion Criteria:

* Metastatic malignancies to ovaries.
Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer

The investigator's study is a single armed phrase II trial ,aiming to improve the effecacy of treatment for advanced billiary tract cancer by means of Toripalimab combining with S1 and Albumin Paclitaxel as first line in patients with advanced Biliary Tract Cancer. treatment continually until disease progression or intolerable toxicity or Patients withdrawal of consent.and target sample is 30+ patients.

Toripalimab: 240 mg , once every 2-3 weeks; S1: 80-120mg, bid; oral, day1-14; Albumin paclitaxel: 120mg/m2 , administered on the first day and the eighth day of each cycle; 21 days for a treatment cycle

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Patients with gallbladder and cholangiocarcinoma diagnosed by histology or cytology
3. Liver function Child-Pugh grade A (5-6 points) or better grade B (≤ 7 points)
4. ECOG score 0 or 1 point
5. At least one measurable lesion
6. no previous treatment

Exclusion Criteria:

1. organs failure ,including liver ,heart ,kidney
2. Have received a liver transplant in the past
3. Active brain metastasis or spinal cord compression
4. ECOG score 3 or 4 point
5. Symptomatic peripheral neuropathy (CTCAE ≥ 2)
Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

To determine if robotically-assisted UKA results in more consistent and improved component positioning and better patient reported outcome scores compared to manual TKA and MAKO TKA.

The purpose of this study is to determine the early clinical and radiographic outcomes of robotically-assisted medial unicompartmental knee arthroplasty (mUKA) with the MAKO surgical robot using the Restoris MCK Partial Implant System. The primary end point will be the mean weekly VAS pain score during the first four weeks postoperatively. The results of this study may be compared to those of previously studied cohorts of patients from this institution who underwent manual total knee arthroplasty (TKA) with the Triathlon Knee System as well as robotically-assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon Knee System

Eligibility Criteria:
Inclusion Criteria:

A. Unilateral primary medial unicompartmental knee arthroplasty

B. Age 18 years of age or older

C. Willing to sign informed consent

D. Willing to return for all follow-up visits

E. Smartphone or tablet device capable of running the FocusMotion platform

Exclusion Criteria:

A. BMI \> 40

B. Personal history of DVT or PE

C. Inflammatory arthritis

D. Peripheral vascular disease

E. Opioid use greater than 5 days per week

F. Nonsteroidal anti-inflammatory allergy

G. Walking aid for musculoskeletal or neurologic issue other than operative joint

H. Bilateral medial unicompartmental knee arthroplasty

I. Patient with an active infection or suspected infection in the operative joint

J. The absolute and relative contraindications stated in the FDA cleared labeling for the device
Management of Occasional or Anticipatory Stress by Consumers of a Food Supplement

Volunteers will fill out an initial questionnaire which will describe their current situation, their pathologies and current treatments, their medical history.

Finally, they will complete three questionnaires on the day of their stressful event which will describe their state of stress just before taking the product, 20 minutes after taking the product; their tolerance and satisfaction with the product will be described at the end of the day.

Participants in the survey will come from a panel of volunteers. They will be contacted via an email proposing the survey accompanied by a selection questionnaire. Eligible volunteers will be called by the clinical investigation center to confirm their participation.

Volunteers will fill out an initial questionnaire which will describe their current situation (sex, age, family and professional situation, cigarette consumption), their pathologies and current treatments, their medical history (disorders related to sleep, stress, anxiety, burnout, depression or other mental disorders).

Finally, they will complete three questionnaires on the day of their stressful event which will describe their state of stress just before taking the product, 20 minutes after taking the product; their tolerance and satisfaction with the product will be described at the end of the day.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old)
* PSS Questionnaire (Perceived Stress Scale) ≥ 14
* Believing that they could be exposed to a stressful event in the next 2 months

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Currently taking a treatment from the following list: antihypertensives, immunosuppressants, antidepressants/barbiturates, anxiolytics, vitamin K antagonists (warfarin, acenocoumarol, fluindione), miconazole, anticonvulsants (carbamazepine, phenobarbital, phenytoin, oxcarbazepine...) and/or anti -infectious (rifampicin, rifabutin, efavirenz, nevirapine, griseofulvin)
* With diabetes, autoimmune disease or hypotension
* Currently taking a medication or dietary supplement that may affect mood, stress, sleep or anxiety
* Currently using products containing any of the following ingredients: hawthorn, ashwagandha (Withania somnifera), bacopa monnieri, black grass, holy basil (Ocimum sanctum), fig buds, CBD, Eleutherococcus, Eschscholtzia, ginseng, griffonia, hops, oil lavender essential oil, marjoram essential oil, lavender hydrolyzate, milk protein hydrolyzate (Lactium), inositol, magnesium, lemon balm, St. John's wort, angelica orange, passionflower, rhodiola, saffron, theanine, asparagus stalk, tryptophan, valerian
* Having known allergies to the ingredients of the product (theanine, rhodiola, passionflower and lavender)
Research on the Effect of Noise Cancelling Headphones in Reducing Postoperative Pain

this randomized controlled trial selects patients undergoing gynecological laparoscopy under general anesthesia. By using noise reduction earphones during surgery, the patient's postoperative pain score and demand for opioids are observed, providing a basis and reference for the efficacy and safety of noise reduction earphones in gynecological endoscopic surgery.

Every year, 200 million surgical procedures are performed worldwide, and 40-65% of patients experience moderate to severe pain after surgery Failure to provide sufficient postoperative analgesia increases the risk of surgical complications and affects patients' early activity and recovery . Opioids are still the main method of treatment, and their side effects include urinary retention, itching, nausea, vomiting, postoperative intestinal obstruction, dizziness and cognitive impairment . Researchers pay more and more attention to non pharmacology and non-invasive analgesia methods, including music therapy, traditional Chinese medicine acupuncture and moxibustion and watching educational videos . Due to the introduction of various surgical tools, the noise pollution in the operating room has gradually intensified, affecting surgical patients and medical staff. Previous studies have shown that general anesthesia does not hinder the brain's processing ability for sound and language; The patient's auditory cortex remains active , and even in anesthesia induced coma, the patient can still maintain the ability to understand auditory information. Other recent studies have found that intraoperative exposure to positive auditory stimuli, including music, treatment suggestions and white noise, can reduce postoperative pain, environmental protection, and acupuncture and moxibustion can also have a similar positive impact . Therefore, this randomized controlled trial selects patients undergoing gynecological laparoscopy under general anesthesia. By using noise reduction earphones during surgery, the patient's postoperative pain score and demand for opioids are observed, providing a basis and reference for the efficacy and safety of noise reduction earphones in gynecological endoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

ASA grade I or II, aged 18-55 years , female were selected for gynecological laparoscopy under elective general anesthesia. -

Exclusion Criteria:

History of serious illness requiring further care in the intensive care unit after surgery; Abnormal hearing; Postoperative mechanical ventilation or continued anesthesia or sedation is required; Preoperative chronic pain or long-term use of painkillers; other factors that hinder patients from cooperating with the research plan

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Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy

The aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps.

Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.


Eligibility Criteria:
Inclusion criteria:

* Men or women between 20 and 100 years of age

Exclusion Criteria:

* Exclusion criteria include age less than 20 years old
* Pregnant, American Society of Anesthesiologists class III and IV
* Overweight (body weight \> 100 kg)
* Allergic to the drugs used or its components (soybeans or eggs)
* Poor bowel preparation or post-colorectal surgery.
Comparative Study of Techniques in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo

Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP (Melanocyte Keratinocyte Transplantation Procedure). Multiple studies have found this procedure to be both safe and effective for the treatment of vitiligo. The majority of these studies utilized trypsin to help isolate melanocytes and keratinocytes. Trypsin is enzyme that helps to separate the different layers of skin. However, some cell biologists believe that the enzyme dispase (which can be used to separate the epidermis from the dermis) is less toxic to cells of the epidermis and can result in a greater number of viable melanocytes and keratinocytes for transplantation.

This study will look at the repigmentation rates of MKTP using trypsin to isolate cells, versus MKTP using dispase to isolate cells.


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years old
2. Have a diagnosis of generalized vitiligo-vitiligo affecting both sides of the body on one or more areas of the body (extremities, trunk, etc.)
3. Have stable vitiligo, defined as no new lesion development (or expansion of existing lesions) in the 6 months prior to proposed procedure date
4. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
5. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

1. Female patients self-reported to be lactating, pregnant, or planning to become pregnant
2. Patients with a history of developing vitiligo or hypertrophic scars at sites of trauma
3. Patients self-reported as having HIV or Hepatitis C
4. Patients self-reported as having uncontrolled Diabetes Mellitus
5. The investigator feels the patient should not participate in the study for any reason
6. Patients with acral vitiligo, defined as significant involvement of the fingers and/or toes
7. Patients with focal or segmental vitiligo, defined as vitiligo affecting only one area of the body on only one side of the body
8. Patients with vitiligo affecting greater than 30% of their body surface area
CYP2D6 Screening for Adverse Drug Reactions to Codeine in Breast Milk

The purpose of this study is to determine if non-invasive salivary genetic screening of breastfeeding mothers taking codeine will allow for the successful identification of mother-infant pairs susceptible to adverse events and to prevent these adverse events by personalizing their medication to their genetics.

Currently, the opioid analgesic codeine is commonly administered to breastfeeding mothers after Caesarean section for pain relief. Codeine was originally considered safe to use while breastfeeding however, increased risk of adverse drug reactions has been demonstrated in mothers taking codeine, as well as their breastfed infants, when the mother possesses a genetic variation resulting in cytochrome P450 2D6 (CYP2D6) ultra-rapid metabolizer (UM) phenotype. On average, most people convert about 10-15% of their codeine dose to morphine resulting in pain relief however, UM individuals can convert up to 50% of their codeine doses into active morphine. As many as 4% of North Americans may be UMs and these mothers and their breastfed infants are at high risk of serious adverse events despite "safe" codeine dosing due to morphine overproduction and accumulation in the mother and her breast milk. Observed side effects include severe sedation, decreased rate and depth of breathing and even infant death. In response to this problem, our hospital-based clinical trial strives to identify at-risk UM mother-infant pairs by performing a genetic test on non-invasive, voluntary saliva samples from mothers giving birth by Caesarean section and who will need codeine for pain relief while breastfeeding. We believe that this test will allow us to reliably identify at-risk UM mother-infant pairs and prevent adverse drug reactions in both by tailoring analgesic therapy to their genetic results: mothers identified as being UMs will be given other suitable analgesics, such as ibuprofen, in place of codeine-containing preparations. We propose that this prospective study will generate high-level data supporting the cost-effective genetic screening of mothers who will be taking codeine while breastfeeding before they begin taking their medications. Such testing is currently possible on a nation-wide scale through collaboration with the Canadian Pharmacogenomics Network for Drug Safety (CPNDS).

Eligibility Criteria:
Inclusion Criteria:

Women who:

* Have a pre-scheduled Caesarean section
* Provide DNA for CYP2D6 genetic analysis
* Breastfeed their infants
* Take codeine-containing medication during breastfeeding (retrospective screening group and non-CYP2D6 ultrarapid metabolizers in prospective screening group)

Exclusion Criteria:

* Mothers who do not provide consent prior to Caesarian section surgery
* Mothers who take other sedative medications besides codeine during breastfeeding (these include benzodiazepines, skeletal muscle relaxants, psychotropic agents).
The Door to the Womb at Birth: Haptonomy

Purpose: This study aimed to examine the effect of haptonomy application on the expectant mother's birth expectations, experiences, birth self-efficacy, birth memory and reminder during labor.

Materials and Methods: The prospective, double-blind, randomized controlled study is conducted between 10.10.2023-10.08.2024, with n=80 (40=control, 40=intervention) women volunteering to participate in the study randomly in two groups: intervention and control. In the study, the Personal Data Collection Form prepared by reviewing the literature, Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version, Labor Self-Efficacy Scale (DEÖÖ) and Birth Memory and Recall Scale (DHÖ) were used.


Eligibility Criteria:
Inclusion Criteria:

* Married and pregnant women,
* ≥ 18 years old,
* Able to read, write and understand Turkish,
* Living in the city center where the study is conducted,
* Does not have any physical or psychological health problems for herself or her baby,
* Having a spontaneous pregnancy at 28.\< gestational weeks,
* Those who have not received haptonomy application before,
* Pregnant women who agreed to participate in the study were included.

Exclusion Criteria:

* Those with psychological and chronic health problems,
* Pregnant women who did not agree to participate in the study were not included.
InO - A Retrospective Study of UK Patients With Leukaemia

The purpose of this study is to describe the demographics and clinical characteristics, treatment pathway, and effectiveness and safety of inotuzumab ozogamicin in patients with relapsed/refractory B-cell acute lymphoblastic leukaemia treated with inotuzumab ozogamicin in the real-world.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed/refractory ALL.
* Patients who initiated InO between 1st of June 2016 and date of data collection.
* Patients who accessed InO treatment via NHS commissioning, via the CUP, or via private purchase.
* Patient aged ≥18 years old at initiation of InO treatment

Exclusion Criteria:

* Patients initiated on treatment with InO at a different hospital than the ones selected in this study.
* Patients with \<3 months of follow-up since index date, unless death occurs \<3 months from index date.
Relationship Between Periodontal Health Status, Body Mass Index and Quality of Diet in a Sample of Adult Patients.

The study is a cross-sectional study investigating the relationship between periodontal health condition, body mass index and quality of diet on adult Egyptian dental patients attending the oral diagnostic center at faculty of Dentistry, Cairo University.

The faculty of Dentistry, Cairo University is an open public facility, a tertiary healthcare and a referral center

* Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
* Medical history will be taken, thorough oral examination will be done, and a full questionnaire will be filled for each patient.
* Before filling the questionnaire, the aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received.
* Non-respondent patients or patients refusing to participate will be reported with the cause of their refusal.
* The questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions.
* Full questionnaire will be filled, then full mouth periodontal examination and charting will be done for each patient.
* The interview questions will be prepared in English, translated into Arabic and then reverse translated by a certified translator to ensure accuracy.
* All the interviews will be done by the same investigator.
* Convetional Clinical examination will be held on a dental unit using the light of the unit and a mirror.
* Periodontal health status will be evaluated by full mouth charting using UNC 15 periodontal probe, including assessment of Probing Depth (PD), Clinical Attachment Level (CAL), Bleeding on probing (BOP), plaque index (PI), body mass index (BMI) and health eating index (HEI).
* The questionnaire which was applied in study will include the following:

  1. Questions including section for demographic information of age, gender, marital status, income, weight, length.
  2. Dietary habits were self-reported through completion of a short form of a validated food frequency questionnaire (Ruiz-Cabello et al., 2017).

Eligibility Criteria:
Inclusion Criteria:

1. Patients whose age is between 18-70 years old.
2. Provide informed consent.
3. Patient have at least 20 natural teeth.
4. Patient had no received periodontal treatment within previous 4 months.

Exclusion Criteria:

1. Individuals with chronic systemic diseases such as cancer, osteoporosis, endocrine and hematological Pathologies.
2. Patients having problem in opening their mouth or undergoing inter-maxillary fixation where oral examination will not be possible.
3. Pregnant women.
4. Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
5. Patients with orthodontic appliances.
6. Patient had autoimmune condition.
7. All patients require prophylaxis at least those attending the diagnostic center.
Molecular Effects of Topical Calcipotriene on Morphea

This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea lesions before and after treatment with topical calcipotriene 0.005% ointment will be analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be obtained and used for a control. This is an initial study to look at the molecular effects of topical calcipotriene on human morphea-involved skin. This study will look at the differences between affected and unaffected skin. This study also will look at clinical outcomes in morphea patients and determine if there are any clinical predictors for improvement with the medication.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with clinically-diagnosed or biopsy proven plaque-type, guttate, linear, segmental, and generalized morphea that are receiving calcipotriene 0.005% ointment as part of their standard of care treatment will be included.
* Subjects are allowed to have previously been on any therapy as long as they have been off systemic treatment, topical therapy or phototherapy for 4 weeks prior to baseline.
* Age ≥ 18 years.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Subjects with the diagnosis of morphea profundus, eosinophilic fasciitis, and atrophoderma will be excluded.
* Subjects who are receiving oral or topical immunosuppression therapy or phototherapy within 4 weeks prior to entering the study.
* Subjects may not be receiving any investigational agents.
* Subjects must not be pregnant or nursing.
* Patients allergic to lidocaine or epinephrine or who have a history of impaired wound healing or for any reason are unable to undergo a skin biopsy.
BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas

The aim of this study (\*) is to evaluate the progression free survival rate at 6 months, response rate, overall disease control rate, overall survival of BAY-43-9006 in soft tissue sarcoma patients.

(\*) as per Protocol Amendment No. 1 of 16 April 2007 approved by local IEC on 24 July 2007


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented, progressive, advanced or metastatic sarcoma after adjuvant and/or first line anthracycline-based regimen; age \>=18 yrs; ECOG PS =2; at least 1 measurable target lesion; life expectancy \>=12 wks; adequate medullary liver and renal function; written informed consent.

Exclusion Criteria:

* metastatic brain disease; pregnant or breast-feeding patients; serious infections.