cyrilzakka/clinical-trials huggingface dataset:
Effect on Dynamic Postural Stability After Application of Cryotherapy to the Knee Joint

The purpose of this study will determine the effect of cryotherapy applied to the knee joint on static and dynamic standing balance. It is hypothesized that there will be no change in dynamic postural stability after cryotherapy application.Twenty four individuals (age 18 to 30) participated in the study. They will be randomly divided into two groups, experimental and control group. Each participant, in the experimental group will be asked to perform star excursion balance test (SEBT) under two conditions, before and after the application of cryotherapy. The participants will receive ice pack wrapping of the knee for 10 minutes. The control group performed SEBT at room temperature in an interval of 10 minutes. The two group will be analysed and compared

The cooling procedure for the knee joint was initiated by using a cryopack or cold-pack. On completion of the initial SEBT, the participant lied supine and the investigator applied the cryotherapy for 10 minutes. After the 10 minute period of cryotherapy, the cryopack was removed, and the participants performed SEBT for the second time.

Eligibility Criteria:
Inclusion Criteria:

* Normal adult person.
* Aged between 18 to 30 year
* Both male and female were included in the study

Exclusion Criteria:

* Adult having any visual impairment
* Adult having any vestibular impairment
* Adult suffering from any neurological disorders
* Adult suffering from other medical conditions, like- Vascular diseases
* Adult having any disorders or conditions like- Genu valgum, Genu varum, history of knee joint or lower limb injury, or lower limb fracture
Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants

The main purpose of this study is to learn about how H2 antagonist (ranitidine) and proton pump inhibitor (PPI) (omeprazole) affect Selpercatinib in healthy participants. Information about safety and tolerability will be collected. The study will last up to about 9 weeks, inclusive of screening period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
* Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2
Predictive Value of the "Cytocapacity Test" Patients With Lymphoproliferative Diseases and High-dose Therapy

This investigator initiated trial was a prospective, open, single-arm, diagnostic-prognostic study. Patients who received high-dose therapy with autologous stem cell transplantation for the treatment of their lymphoproliferative disease were included into the study.

After completion of the high-dose therapy (day -2 with respect to the stem cell transplantation) the first blood sample A for the cytocapacity test with determination of leukocytes and neutrophils was taken in the evening of day -1. Directly thereafter the study medication was administered. The second blood sample B for the cytocapacity test with determination of leukocytes and neutrophils was taken in the morning of day 0, 12-14 hours after administration of the study medication. Thereafter the stem cell re-infusion was performed.

The primary objective of this study was to show that the cytocapacity test with lenograstim is a useful predictive tool with respect to the risk of post-transplant complications and prolonged myelosuppression, typically occurring after high-dose chemotherapy.

The primary variables were:

* the rate of patients with documented infections
* the time to platelet engraftment


Eligibility Criteria:
Inclusion Criteria:

* Presence of histologically proven lymphoproliferative disease specified as Hodgkin's disease, non-Hodgkin's lymphoma (NHL) or multiple myeloma
* Indication of high-dose therapy and autologous peripheral blood stem cell transplantation
* Availability of a sufficient amount of blood stem cells (CD34+ cells \>= 2.0 x 106/kg)
* Age between 18 and 70 years
* High-dose therapy with one of the following high-dose regimes: Melphalan 140 mg/m2 or 200 mg/m2, BEAM, BEAC, BUCY or CBV (the last permitted according to amendment 2, see Section 9.8.1)
* Patient's written consent to participation in this trial

Exclusion Criteria:

* Previous high-dose therapy and blood stem cell transplantation except for melphalan 140 mg/m2 or 200 mg/m2 in patients with multiple myeloma who did not participate in the cytocapacity test previously (according to amendment 2, see Section 9.8.1).
* Known intolerance to lenograstim
* Out-patient therapy following high-dose therapy and blood stem cell transplantation
* Myocardial infarction \< 6 months prior to inclusion into the study
* Cardiac arrhythmias Lown IV b
* Clinically manifest cardiac insufficiency (\> NYHA II)
* Renal insufficiency with serum creatinine \> 2 mg%
* Hepatic diseases with elevated levels of transaminases and bilirubin greater than 3-fold above normal
* Severe infections (HIV, Hepatitis B/C)
* Severe psychiatric diseases
* Non-curative treatment of other malignoma within the past 5 years
* Pregnant women or women breast-feeding
RhEGF Incorporated in An Absorbable Collagen Membrane for The Management Of Gingival Recession Defects

A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

IN TEST SITE :

Local anesthesia will be administered and Vertical incisions will be given at interdental papillae away from recession defect site and a pouch will be created. A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

IN CONTROL SITE:

Same procedure will be done as the test site but plain collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy male and female patients of age 20-55 yrs with Millers class I or class II gingival recession are included in the study.

Exclusion Criteria:

* Patients who are medically compromised and Subjects who underwent radiotherapy or chemotherapy and who are Smokers are excluded from the study
Pilot Study: Preoperative Nicotine Lozenges

The goal of this pilot study is to determine the feasibility and potential effect size of nicotine lozenges as an adjunct to maintain brief preoperative abstinence, defined as not smoking the day of surgery.

Nicotine replacement therapy (NRT) helps patients maintain prolonged abstinence; whether it might also be efficacious in helping smokers maintain preoperative "fasting" from smoking is not known. A goal of this study is to determine how to best decrease smokers' exposure to cigarette smoke immediately before surgery. The specific aim of this study is to test the hypothesis that NRT in the form of nicotine lozenges will decrease the exposure to cigarette smoke prior to surgery. This is a randomized, double blinded, placebo controlled clinical trial examining the efficacy of the nicotine lozenge in increasing preoperative abstinence from cigarettes in patients scheduled for elective surgery. Current smokers scheduled for any of a wide variety of elective surgical procedures will be recruited in the Mayo Clinic Rochester Preoperative Evaluation Center. and will receive a brief practice-based intervention encouraging preoperative abstinence for at least 12 hours before admission to the surgical facility. They will be randomized to receive either active or placebo lozenge.

Eligibility Criteria:
Inclusion Criteria:

* Current cigarette smoker, defined as \>100 cigarettes lifetime consumption and self report of smoking every day
* Scheduled for elective non-cardiac surgery

Exclusion Criteria:

* An inability to understand consent procedures
* History of an allergic reaction to nicotine replacement therapy
* History of sustained ventricular tachycardia
* Untreated hyperthyroidism or pheochromocytoma
* Currently utilizing pharmacologic agents specifically to treat nicotine dependence, including nicotine replacement therapy and bupropion (for a stop-smoking indication)
* Active (within the past 12 months) non-nicotine drug dependence
* Females who are pregnant or lactating
* Patients with phenylketonuria, because the lozenges contain aspartame, which is metabolized to phenylalanine.
* Lack of access to a telephone, as one follow-up will be performed using this means.
Virtual Reality in the Operating Room

This is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements.

The proposed study is a randomized, controlled trial to evaluate the effectiveness of VR as an adjunct to standard anesthetic practice for upper extremity surgery. Patients will be randomized to undergo immersion relaxation via the use of VR during their procedure or control. In both groups patients will undergo regional anesthesia preoperatively according to standard practice. Patients will then be assessed postoperatively to assess the intraoperative propofol dose between groups, as well as secondary outcomes including patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing upper extremity (hand, wrist, arm, and/or elbow) surgery at BIDMC under MAC

Exclusion Criteria:

* Age \< 18
* Open wounds or active infection of the face or eye area
* History of seizures or other symptom linked to an epileptic condition
* Patients who plan to wear hearing aids during the procedure
* Patients with a pacemaker or other implanted medical device
* Droplet or airborne precautions (as determined by BIDMC infection control policy)
* Non-English speaking
* Patients who require deep sedation
* Patients who are deemed ineligible to approach by the surgeon
Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt

This study will test the efficacy of the NASG on women suffering from obstetric hemorrhage as compared to hemorrhaging women who do not receive the NASG.

This is a comparative, pre-post study of the Non-pneumatic Anti-Shock Garment (NASG) to establish its effectiveness in reducing maternal mortality and morbidity due to obstetrical hemorrhage. The sites are two maternity teaching hospitals in Egypt: El Galaa, in Cairo and Assiut University in Assiut.

Our main aim was to test the efficacy of the NASG on women suffering from obstetric hemorrhage as compared to hemorrhaging women who do not receive the NASG. Our primary outcome was Extreme Adverse Outcomes (EAO) - a combined outcome of maternal mortality and severe morbidity. Secondary outcomes included mean measured blood loss and incidence of emergency hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* blood loss from obstetric hemorrhage \>= 1000 mL
* pulse \> 100 beats per minute or systolic blood pressure \< 100 mmHg

Exclusion Criteria:

Absolute exclusion criteria:

* current viable third trimester intrauterine pregnancy that can be delivered in the next 20 minutes after hemorrhage begins
* current bleeding sites above the diaphragm.

Relative exclusion criteria:

* history or current clinical evidence of mitral stenosis or congestive heart failure (CHF)
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone

Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs between BI 201335 and either methadone or buprenorphine/naloxone.


Eligibility Criteria:
Inclusion criteria:

1. stable dose of either methadone or buprenorphine/naloxone for 30 days for opioid maintenance therapy.
2. Male and female volunteers with a body mass index (BMI) = 18.5 and \< 32 with a minimum weight of 50kg.

Exclusion criteria:

1. any other significant medical illness of clinical significance.
2. history of rash or photosensitivity
3. chronic or acute infections including HIV, hepatitis B and hepatitis C.
4. history of allergy considered significant for this study
5. intake of any other medications except for methadone or buprenorphine/naloxone.
6. QTc on electrocardiogram (ECG) \> 470.
7. use of any other investigational drug within 30 days of the study.
8. drug or alcohol abuse (other than the defined opioid maintenance therapy with either methadone or buprenorphine/naloxone)
9. blood donation of more than 100mL within four weeks of the trial.
10. excessive physical activities one week prior to and during the trial.
11. any clinically relevant laboratory value.
12. concomitant use of any food product known to alter P450 or P-gp activity such as grapefruit juice, seville oranges and St. John's Wort.
13. inadequate venous access

    For women of childbearing potential:
14. pregnancy or planning to become pregnant within 3 months of the trial
15. positive pregnancy test at screening visit
16. no proof of sterilization or unwilling or unable to use a double barrier method of birth control during the study and up to 3 months after the study.
17. lactation with active breastfeeding from screening up to 30 days after last study visit.
Internet Assisted Obesity Treatment

High quality behavioral weight loss programs are not widely accessible. The Internet offers one way to deliver health behavior programs to a wider audience. However, effective weight loss treatments are intensive and program delivery over the Internet may not be capable of duplicating the level of engagement typically generated during traditional in-person treatment. The goal of this study is to test the effectiveness of three weight loss interventions: Internet alone, Internet+periodic in-person support, and in-person alone. The investigators hypothesize that the in-person and internet+in-person interventions will produce better weight loss and maintenance than the internet only group.

Currently 65% of the adult population is overweight or obese. Unfortunately, safe and effective treatments for obesity are costly and intensive; therefore, this level of support is unlikely to be feasible in most clinical settings. Moreover, an additional limitation to current obesity treatment approaches is the limited reach and availability of programs for persons who work, live in rural areas or do not want, or cannot afford participation in group support classes. The advent of telecommunications technology may provide a solution to this dilemma. Telecommunications technology can presumably improve access to services and improve efficiency of delivery. Moreover, research examining new technologies such as the Internet, will provide information for policy makers interested in disseminating low-cost, high reach effective obesity treatment interventions. However, the effectiveness of the Internet for inducing weight loss has not been rigorously tested. Therefore, the overall goal of this project is to determine if obesity treatment can be effectively delivered over the Internet. A secondary aim is to evaluate whether the effectiveness of Internet interventions can be improved with the addition of minimal in-person support. Specifically, this project is a randomized, controlled clinical trial designed to test the translation of a behavioral weight loss program to the Internet (I). The I intervention will be compared to both an in-person condition (IP) and an Internet condition supplemented with periodic in-person support (I+IP). Subjects will be 488 (30% minority) overweight and obese adults recruited from Vermont and Arkansas who will participate in a 6-month behavioral weight control treatment program followed by 12 months of weight maintenance. Assessments will include measures of body weight, adherence to treatment goals, social influence components and frequency of use of Internet website features.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* BMI\>25
* Internet access

Exclusion Criteria:

* pregnancy
* major medical problems
* inability to walk for exercise
Ingenol Mebutate Gel 0.05% in Kidney Transplant Recipients With Actinic Keratoses

The substance ingenol mebutate (IM) is registered in Switzerland and many countries worldwide for the treatment of actinic keratosis (AK). There is no data on the use of IM in organ transplant recipients, a population highly affected by AK and skin cancer at large. The investigators want to study the use of IM against AK in this high-risk group of patients and assess its safety. The investigators are hoping to prove that IM is safe to use in AK of organ transplant recipients, allowing its use in the clinical routine treatement of AK also in this subset of patients with AK.

Ingenol mebutate gel, 0.05%, commercially supplied in a box of 2 single use, unit dose tubes for topical application for each 25cm2, four conjunctive 25cm2 areas (100cm2) will be treated. If the 100 cm2 area is not cleared at Day 57 (+/- 3 Days), a second treatment cycle will be initiated with commercially supplied drug in a box of 2 single use, unit dose tubes for topical application for each 25cm2 and four conjunctive 25cm2 areas (100cm2 ) will be treated. In total for the first cycle, 4 commercially supplied boxes (8 unit dose tubes) will be used, and for the second cycle an additional 4 commercially supplied boxes (8 unit dose tubes) will be used (in total 8 boxes, 16 unit dose tubes per patient).

Eligibility Criteria:
Inclusion Criteria:

* Male subjects 18 years of age or older
* Female subjects 18 years of age or older of non-child bearing potential defined by a serum follicle stimulating hormone (FSH) level ≥ 25.8 mIU/ml or by a confirmed clinical history of sterility (e.g. hysterectomy)
* Renal transplantation performed two years or more before inclusion
* Stable renal transplant function as determined by physician
* Actinic keratosis, one or multiple, of the trunk and/or extremities, non-hypertrophic non-hyperkeratotic based on clinical judgment within an area of 100 cm2 total (several areas adding up to 100 cm2 permissible)
* Signed Informed Consent after oral and written explanation of the study protocol

Exclusion Criteria:

* contraindications on ethical grounds such as inability to give informed consent
* women of child-bearing potential, women who are pregnant or breast feeding
* other clinically significant concomitant disease (e.g. hepatic dysfunction, cardiovascular disease, etc) at the investigator's discretion
* known or suspected non-compliance, drug or alcohol abuse
* enrolment into a clinical trial within last 4 weeks
* prior treatment with ingenol mebutate gel
* prior local/topical treatments in the treatment area within 2 weeks of trial entry:

  * Dermabrasion, chemical peeling, laser treatment, cryotherapy or surgery
  * Imiquimod, diclofenac, 5-Fluorouracil (5-FU), topical corticosteroids, topical retinoids, treatment with ultraviolet B (UVB) or photodynamic treatment (PDT)
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer

The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CAPOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.

On April 16, 2021, the Food and Drug Administration approved first-line therapy with nivolumab and fluoropyrimidine-platinum-containing chemotherapy for metastatic gastric adenocarcinoma. Patients with PD-L1 expression benefit the most from this treatment.

Fibroblast growth factor receptor 2 (FGFR2) is a predictor of poor overall survival and a potential target for targeted therapy. However, there is no data of nivolumab efficacy in patients with combined expression of PD-L1 and FGFR2.

The aim of this study is to evaluate the preliminary efficacy of nivolumab in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated, unresectable advanced or metastatic gastric adenocarcinoma
* Measurable lesions according to the RECIST 1.1 criteria
* PD-L1 Combined Positive Score (CPS) of five or more assessed by Dako PD-L1 immunohistochemistry 28-8 pharmDx assay
* Positive FGFR2 overexpression status by immunohistochemistry defined as exhibiting any moderate (2+) to strong (3+) membranous staining in more than 1% of tumor cells
* Possibility to assess the amplification of FGFR2
* HER2-negative status
* ECOG PS 0-2
* Age \>= 18 years old
* Adequate function of organs
* Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study
* Signed Informed Consent

Exclusion Criteria:

* Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study
* Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study
* Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study
* Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease
* Pregnancy
* Known positive status for human immunodeficiency virus (HIV) or active hapatitis B and C
* Surgery within 7 days before the first dose of the study drug
* Signs of bleeding or hemorrhagic diathesis