cyrilzakka/clinical-trials huggingface dataset:
An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants

The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Weight ≥ 50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive at screening
* Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study
* A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months before screening

Exclusion Criteria:

* Previous participation in the current study or previous exposure within 6 weeks before study drug administration for non-biologics and 12 weeks before study drug administration for biologics
* Inability to tolerate oral medication
* Inability to tolerate venipuncture, or inadequate venous access

Other protocol defined inclusion/exclusion criteria could apply
Transfusion Requirements After Orthotopic Liver Transplantation

The objective of this trial is to evaluate different transfusion strategies in patients after liver transplantation. Patients in the experimental arm will be given red blood cell (RBC) transfusion according to a liberal strategy, i. e., transfusions should be given, when hemoglobin concentration falls below 10 g/dl, and hemoglobin concentration should be maintained between 10 and 12 g/dl. Patients in the control arm will be given red blood cell (RBC) transfusion according to a restrictive strategy, i. e., transfusions should be given, when hemoglobin concentration falls below 8 g/dl, and hemoglobin concentration should be maintained between 8 and 10 g/dl.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing liver transplantation
* Patients considered to have euvolemia after initial treatment by attending physicians

Exclusion Criteria:

* Patients age 18 or less
* Patients undergoing combined liver-kidney transplantation
* Patients requiring renal replacement therapy before liver transplantation for longer than two weeks
* Inability to receive blood products
* Patient with active blood loss at the time of enrollment
* Pregnancy
* Imminent death
Blood Sparing Strategies: Single Shot High Dose Erythropoietin Two Days Before Heart Surgery

All patients operated on at the European Hospital Heart surgery Division will be randomized to either single dose 80.000 UI of Human Recombinant Erythropoietin and intravenous iron or control.

Primary end point is the amount of transfused blood. Secondary end point is the Hemoglobin level in the patient on postoperative day four.

Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well

Growing evidence points out blood transfusion as a major determinant in medium and long term prognosis as regarding heart surgery population. Moreover blood has become a scarce resource, thus often delaying intervention due to lack of availability.

Previous studies at our Hospital have shown that high dose Human Recombinant Erythropoietin (HRE)effectively spares transfusions even when administered two days before surgery. The previous protocol was fragmented into 5 administration which proved to be unpractical even if effective.

After multidisciplinal discussion with nephrologists and transfusionists a new protocol was established: 80.000 UI in a single dose at time of arrival at the hospital. There are no exclusion criteria planned.

Our primary end point is the amount of transfused blood. Our secondary end point is the Hemoglobin level in the patient on postoperative day four.

Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well.

Eligibility Criteria:
Inclusion Criteria:

* All comers

Exclusion Criteria:

* None
Randomized Study of Accelerated Radial Arterial Hemostasis

Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage

The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, \& N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.

Eligibility Criteria:
Inclusion Criteria:

* Current patients who are undergoing diagnostic and interventional coronary/vascular angiography via a transradial approach with or without planned coronary or peripheral intervention.

Exclusion Criteria:

* None
A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid Tumors

The goal of this study is to obtain safety, tolerability, PK, and preliminary clinical antitumor activity for XL495 as a single agent and in combination with select cytotoxic agents in participants with locally advanced or metastatic tumors for whom life-prolonging therapies do not exist or available therapies are intolerable/no longer effective.


Eligibility Criteria:
Inclusion Criteria

* For All Participants

  * Have received at least one standard therapy unless it does not exist, or available therapies are intolerable or no longer effective.
  * For participants, who qualify for approved molecularly selected therapies such as RAS inhibitors, they must have progressed on, relapsed from, been intolerant to, ineligible, or refused those therapies.
* Expansion Stage

  * Diagnosis of metastatic advanced UC (primary tumor: renal pelvis, ureter, urinary bladder, or urethra).
  * At least one measurable lesion as defined by RECIST, version 1.1.
  * Participants must be eligible for sacituzumab govitecan treatment as their next line of therapy.
* At least one but no more than 3 prior lines of therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (0-2 for monotherapy; 0-1 for combo)

Exclusion Criteria

* Prior anticancer treatment, including:

  * Radiation therapy within 2 weeks before first dose of study treatment.
* Known brain metastases or cranial epidural disease
* Current or recent severe illness
* Known history or positive test for human immunodeficiency virus (HIV) unless meets specific criteria.
* Active infection with hepatitis B virus or hepatitis C virus.
* Malabsorption syndrome.
* History of solid organ, autologous or allogenic stem cell transplant.
* Diagnosis of another cancer within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with standard therapy.
* Active autoimmune disease with skin involvement.
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)

A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.


Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian agrees to have infant participate by giving written informed consent

Exclusion Criteria:

* History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
* History of intussusception
* Known or suspected impairment of immunological function, including Severe

Combined Immunodeficiency (SCID)

* Prior administration of any rotavirus vaccine
* Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)
* Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.
* Residing in a household with an immunocompromised person
* Prior receipt of a blood transfusion or blood products, including immunoglobulins
* Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study
* Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study
A Full Face Study to Evaluate the Efficacy of Dermapen 4™ Microneedling Device in Addition with MG-CLR Serum for Acne Treatment Over 12 Weeks.

This study is conducted to check how well the Dermapen 4™ microneedling device works with MG-CLR serum for treating acne over 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Female subjects aged between 18-45 years (both ages inclusive)
2. Fitzpatrick skin phototype I to VI.
3. Subjects having IGA score of 2 and 3.
4. Subjects who have not received any kind of treatment for acne 1 month before the start of the study.
5. Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other skin conditions on the face.
6. Subjects who agree not to use any other product/treatment/home remedy/ except the provided products on their face during the study period

Exclusion Criteria:

1. Subjects with known skin condition that may impact the assessment.
2. Subjects with active Herpes labialis infection.
3. Subjects known to have bleeding and clotting disorders (self-declared).
4. Subjects known to have connective tissue disorders.
5. Subjects with any other signs of significant local irritation or skin disease.
6. Subjects currently taking any medication, which the investigator believes may influence the interpretation of the data.
Snuff Use, Smoking, Periodontitis and Mortality: 30-year Cohort Study From Sweden

Smoking and dual using associated with poor periodontal health.

Aim: To investigate how snuff use, smoking and risk behaviour affect periodontal health and mortality in a Swedish cohort, hypothesizing that they indeed have a poor impact and increase the risk of death.

Material and methods: Study cohort of 1080 subjects aged 31 to 40 years (528 men and 552 women) from Stockholm area was clinically examined in 1985 and followed for mortality until 2015. Associations between periodontal health parameters, snuff use, smoking and age of death were analysed by classifying all subjects into four groups: "dual-users" (current snuffers and current smokers); "pure snuffers" (current non-smoking snuffers); "pure smokers" (current non-snuffing smokers) and "non-users" (non-snuffers, non-smokers). SPSS was used for analyses.

Eligibility Criteria:
Inclusion Criteria:

* In 1985-1986 a sample was selected from the registry file of all inhabitants of the Stockholm area, of people born on the 20th of any month from 1945 to 1954.The sample comprised 3200 people. They were informed about the purpose of the study and called for clinical investigation. 1681 (52.5%) individuals, 840 men and 841 women, participated in the study. Subjects had different socio-economic and health backgrounds.

Exclusion Criteria:

* Other people. Any disease was not an exclusion criteria.
Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.

This is a randomized double-blinded placebo controlled trial to assess the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years. All subjects complete daily assessments of cold symptoms, nasal clearance rates and secretion rates during each day of the study. Phlebotomy is performed once for the determination of cytokine genotyping and allergy skin testing is performed once for the assessment of atopy.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 50 years of age.
* Male or female, who are not pregnant or lactating.
* Common cold symptoms for less than 24 hours.
* At least 2 of the following 9 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratch throat, sneezing and malaise.

Exclusion Criteria:

* Investigational medication in past 30 days.
* Known hypersensitivity to any ingredients in study medication.
* History of asthma or other chronic diseases.
* Females of childbearing potential who are not using a medically acceptable form of birth control.
* Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
* Females with a positive urinary HCG test.
* Patients with a positive rapid antigen test for streptococcal infection.
* Common cold symptoms for more than 24 hours.
* Patients who are users of illicit drugs.
* Patients who are on rifampin or phenobarbital.
A Study of Tasisulam in Treating Participants With Malignant Melanoma

The primary purpose of this study is to determine the objective response rate (complete and partial response) for participants who receive tasisulam after one prior systemic treatment for unresectable or metastatic melanoma.

Participants will receive a 2-hour intravenous infusion of study drug (tasisulam) once every 28 days. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Participants will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of malignant melanoma that is unresectable or metastatic (Stage III or IV)
* Have received 1 previous systemic treatment regimen for unresectable or metastatic melanoma. An immunotherapy or antibody-based regimen (including vaccination-based treatments) is not counted as a prior treatment regimen for determining study eligibility, unless it was combined with a chemotherapeutic or targeted anti-cancer drug.
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days

Exclusion Criteria:

* Serious pre-existing medical conditions
* Have received two or more previous treatment regimens for unresectable or metastatic melanoma
* Have a second primary cancer (unless disease-free to more than 2 years)
* Active treatment with Warfarin (Coumadin)
* Primary ocular or mucosal melanoma
Cognitive Behavioral Therapy for Painful Diabetic Neuropathy

The primary objective of this study is to evaluate the usefulness of cognitive behavioral therapy (CBT) for the management of painful diabetic neuropathy. Participants will be randomly assigned to one of two treatment conditions: CBT plus standard medical care or standard medical care alone. CBT will be offered in ten, ninety-minute group sessions and will be provided by a psychologist with experience in the management of both diabetes and chronic pain. CBT will involve teaching and encouraging practice of adaptive pain coping skills such as relaxation skills, activity pacing, and positive self-statements, among others. This study will allow us to determine which treatment is superior in terms of improvements in pain management, functioning and overall quality of life.

Research Design: A randomized mixed factorial controlled design will be employed in which CBT plus standard pharmaceutical care (CBT/SC) is compared to a standard pharmaceutical care (SC) treatment condition. Participants will be randomized in equal numbers to the two conditions. Repeated assessments of key outcome domains will occur at pretreatment/baseline and at 12, 24 and 36 weeks following baseline.

Methodology: Study participants will be evaluated pre-treatment (baseline), 12 weeks post-baseline (post-treatment) and at 24 and 36 weeks post-baseline (follow-up). Baseline assessment will include a neurological examination with a nerve conduction study to confirm the diagnosis of diabetic neuropathy. The primary outcome measure will be pain intensity. Secondary outcome measures will be pain quality, pain-related disability, physical and emotional functioning. Measures of treatment feasibility will also be examined. Participants receiving CBT will attend 10 weekly, group treatment sessions of 90 minutes. A target sample size of approximately 120 participants will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* daily lower extremity pain or discomfort (burning, tingling or other parasthesias) for at least 3 months
* documented trial of at least one medication for neuropathic pain
* pain of at least 4 on a 0-10 numeric rating scale

Exclusion Criteria:

* acute medical condition, substance abuse, or psychiatric condition that would impair ability to participate
* dementia (MMSE score of 23 or lower)
Sentinel Node and Endometrial Cancer

The purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.

To investigate the relevance of sentinel node in endometrial cancer. Sentinel node is though to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy. The objective of our trial is to validate the concept of sentinel node in endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

* patient over 18 years old with a surgery planned for endometrial cancer
* endometrial cancer proved by biopsy
* early stage of endometrial cancer (FIGO stage 1-2)
* without contraindication to surgery
* inform consent signed
* affiliated to general health system

Exclusion Criteria:

* endometrial cancer FIGO stages 3-4
* previous history of surgery modifying lymphatic drainage (conization myomectomy)
* pregnant women or breast feeding
I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery

i-gel Plus is a novel supraglottic airway device (SGA). Feasibility of second-generation SGAs in patients undergoing elective laparoscopic surgery has been demonstrated in various studies. During laparoscopic surgery intrabdominal pressure is increased by capnoperitoneum and frequently minute ventilation has to be adopted to counteract hypercapnia, and higher inspiratory peak pressures have to be expected. It is uncertain, however, if the i-gel Plus facilitates appropriate ventilation with low leakage volumes in patients undergoing laparoscopic surgery.

The primary aim of this single-center non-inferiority study is to assess the leak fraction of the i-gel Plus under conditions of capnoperitoneum (with and without Trendelenburg position) and to compare it with baseline conditions. Secondary aims are to assess secondary outcome parameters during capnoperitoneum (with and without Trendelenburg position) and to compare them with baseline conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduling for elective laparoscopic surgery
* Planned airway management using a SGA
* Adult patients (age 18-89 years)
* ASA physical status 1-3

Exclusion Criteria:

* Pregnant or breastfeeding women
* Non-fasted patients
* Increased risk of aspiration or other contraindications for supraglottic mask ventilation
* Body mass index (BMI) \>35 kg/m2
* Inability to understand or sign informed consent
Impact of Moderate Intensity Physical Activities on PK-guided EHL FVIII Concentrates Prophylaxis Severe HA Patients

To compare clinical outcomes before and after using combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis in moderate to severe hemophilia A patients

This is a prospective cohort study of severe hemophilia A patients receiving low-dose EHL FVIII concentrates with PK-guided EHL FVIII concentrates prophylaxis alone for 6 months. Additional exercise workshops from sport scientists were introduced individually to this group of patients along with using the same prophylaxis method for another period of 6 months. The annualized bleeding rates (ABR), the annualized joint bleeding rates (AJBR), the haemophilia-specific quality-of-life (Haemo-QoL-A) scores, the hemophilia Joint Health Scores (HJHS) and skeletal muscle mass were compared between these two periods

Eligibility Criteria:
Inclusion Criteria:

* Severe Hemophilia A patients

Exclusion Criteria:

-
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)

The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation.

Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen.

The third objective of this study is to evaluate who may benifit from this treatment regimen.

Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage III, IVa and IVb NPC.

Eligibility Criteria:
Inclusion Criteria:

* -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
* Stage Ⅲ, IVa and IVb disease
* KPS \>70
* Age between 18-70
* Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \> 2000 cells/mm3, platelet count of \> 100,000 cells/mm3 (pre treatment without intervention). Bilirubin \< 1.5 mg/dl, AST or ALT\<2 x upper normal, serum creatinine\<1.5mg/dl, creatinine clearance \>50ml/min.
* the primary tumor or involved lymph node must be more than 2CM in diameter.
* No prior radiation treatment to the head and neck or any prior chemotherapy
* Patients with no prior malignancy (not include basal cell carcinoma of skin)

Exclusion Criteria:

* Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
* Prior radiotherapy to the head and neck region for any reason.
* Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
* Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
* Pregnant women