cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Topical Human FGF-1 for Wound Healing

The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of a wound.

Dermal ulcers pose a significant healthcare problem in the United States, ultimately affecting 10-15% of the approximately 20 million patients with diabetes and a similar number of patients with chronic venous insufficiency. Dermal leg and foot ulcers can result from compromised arterial inflow, microvascular perfusion or venous outflow which can lead to amputation unless vascular perfusion is improved. FGF-1 for topical administration offers the possibility of improved microvascular perfusion by promoting the formation of new blood vessels in the wound bed resulting in enhanced development of granulation tissue and accelerated healing.

Eligibility Criteria:
Inclusion Criteria:

1. Sign an informed consent form prior to the initiation of any study procedures. Subjects must be competent to give written informed consent.
2. Age must be between 18 to 75 years of age.
3. Female subject must be post-menopausal or sterilized, or if she is of childbearing potential, she is not breast feeding, and her serum pregnancy test is negative.
4. Subjects must be willing to change their wound dressings daily and demonstrate to study personnel the ability to follow the dressing care instructions indicated in the Appendix. Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.

Exclusion Criteria:

1. Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy.
2. Subjects who, at study entry, are taking systemic antibiotics.
3. Subjects who are immunosuppressed.
4. Subjects experiencing bacterial or viral infection or who may otherwise be febrile.
5. Past history or current presence of any type of cancer (except past history of basal cell carcinoma that is not on the limb being treated). Subjects with existing BCC will be excluded from the study.
6. Life expectancy of less than 1 year.
7. Active alcohol or drug abuse within 6 months prior to study entry.
8. Screening liver function tests of more than 2.0 times the upper limit of normal.
9. Serum creatinine of ≥ 2.5 mg/dl.
10. Hemoglobin A1c (HgbA1c) of \>10%.
11. Exposure to any other investigational drugs or devices or participation in any other investigational studies within 30 days prior to study entry.
12. Any other medical, social, or geographical factor that would make it unlikely that the subject will comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or a history of non-compliance).
Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude

Randomized, placebo controlled trial evaluating the effect of acetazolamide on maximal exercise performance in lowlanders older than 40 years travelling from 760 m to 3'100 m.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide intake on the maximal exercise performance in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.

An interim analysis will be carried out when 80 participants will have completed the study or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, age 40-75 yrs, without any disease and need of medication.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.
* Kyrgyz ethnicity

Exclusion Criteria:

* Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
* Any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol.
* Allergy to acetazolamide and other sulfonamides.
The Effect of Percussion Massage Therapy on the Recovery of DOMS in Physically Active Young Men Delayed Onset Muscle Soreness = DOMS

The goal of this clinical trial is to learn the effect of percussion massage therapy (PMT) on the recovery of delayed onset muscle soreness (DOMS) in physically active young men.

The main question it aims to answer is:

Compared with static stretching, Do 25 minutes and 40 minutes of PMT can decrease pain and increase the rang of motion of knee of low limb DOMS in physically active young men? Compared with static stretching, Do 25 minutes and 40 minutes of PMT sessions can increase power and improve the neuromuscular electrophysiology of low limb DOMS in physically active young men?

Researchers will compare 25 minutes and 40 minutes of PMT to a static stretching to see if different times of PMT are better to treat DOMS.

Participants will： Undergo squats to induce low limb DOMS. Receive static stretching, 25 minutes and 40 minutes of PMT, respectively for three times.

Visit the lab for four times in one week for tests.


Eligibility Criteria:
Inclusion Criteria:

Regularly participate in physical activity, have no contraindications to exercise, and volunteered to participate in this study

Exclusion Criteria:

Participants consumed alcohol and exercised vigorously throughout the formal experiment or they underwent interventions other than those planned for the experiment.
New Topographic Classification of Knee Bone Marrow Lesions

the investigator are studying a new topographic classification of bone marrow lesion in the knee and validating it.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 with mri with lesion consent given

Exclusion Criteria:

* under mri previous surgery tumors no consent
RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment

This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free survival rate (primary end-point) and response rate, toxicity, and overall survival (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer.

Eligibility criteria include histologically proven gastric/gastroesophageal junction cancer who failed previous first-line standard treatment with fluoropyrimidine and platinum-based chemotherapy.

Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted according to the observed clinical toxicities. Treatment will be continued until disease progression or patient's intolerability to the study drug.

Total of 54 patients will be enrolled to decide whether the proportion of patients who are free from progression at 4 months (16 weeks), P, is less that or equal to 0.15 or greater than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate, 10%.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction
* Patients must have non-resectable disease by metastasis or recurrent disease after curative surgical resection with uni-dimensionally measurable disease (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination)
* Patients tumor should have failure of 1st line chemotherapy including fluoropyrimidine (5-FU, capecitabine, doxifluridine, S1, or UFT) and platinum (cisplatin, carboplatin, or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy
* Age 18 to 75 years old
* Estimated life expectancy of more than 3 months
* ECOG performance status of 2 or lower
* Adequate bone marrow function
* Adequate kidney function
* Adequate liver function
* No prior radiation therapy to more than 25 percent of BM
* Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study
* Women of childbearing potential must have a negative pregnancy test on admission
* The patient must be able to understand the study and has given written informed consent to participate in the study

Exclusion Criteria:

* Other tumor types than adenocarcinoma
* Central nervous system metastases or prior radiation for CNS metastasis
* Gastric outlet obstruction or intestinal obstruction
* Evidence of active gastrointestinal bleeding
* Bony metastasis as the sole evaluable disease
* Past or concurrent history of neoplasm other than stomach cancer
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* Thyroid disease
Effect of Exercise on Muscle Proteome Signature

The aim of the study is to investigate skeletal muscle proteome signature changes induced by exercise training in young men

Advances in omics technologies have allowed for the identification of biomarkers with importance for the beneficial adaptations imposed by exercise training. Skeletal muscle exhibits remarkable plasticity to exercise training, as illustrated by pronounced alterations to the proteomic landscape, such as mitochondrial biogenesis. However, despite recent advances that have helped describe the proteomic landscape in response to a period of exercise training, our understanding of the processes pertaining to post-translation modification is scant. In this study, we aim to investigate the human acetylome and proteome in response to exercise training.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* VO2max of 45-55 ml/kg/min (+/- SD) / 3000-4000 ml/min (+/- SD)
* Body mass index (BMI) of 19-26 kg/m2
* Normal ECG (electrocardiography)

Exclusion Criteria:

* Serious adverse effects to exercise
* Chronic disease
Infrared Thermography for Assessment of Caudal Block in Children

Regional analgesia via caudal neuraxial blockade provides pain relief for pediatric patients following urological and lower extremity procedures. The injection of local anesthetic into the caudal epidural space causes a sensory loss. This sympathetic blockade in turn causes a vasodilation, or increased blood flow, to the lower extremities.

The purpose of this study is to determine whether the FLIR ONE thermographic camera, a smartphone attachment which utilizes an application ("app") to measure the temperature at a site on an image of the lower extremity, will be able to differentiate between caudal, non-caudal, and failed caudal images.


Eligibility Criteria:
Inclusion Criteria:

* Children from 6mos to 5 years of age requiring general anesthesia and a caudal block for a surgical procedure

Exclusion Criteria:

* Patients with preexisting conditions that could affect the skin temperature on the lower extremities such as infection, edema, vascular disorder, etc.
* American Society of Anesthesiologists comorbidity ranking of 4 or greater
* Patient with contraindications for a caudal block such as: history of allergic, reactions to local anesthetics, coagulopathy, infection at the injection site, spinal abnormality, peripheral neurological disease, Raynaud's disease
Using Large Language Models Such As GPT-4 to Assess Guideline Adherence in Patients with Chronic Obstructive Pulmonary Disease

According to studies in the US and the Netherlands, 33-40% of patients with chronic conditions receive care that does not follow guideline recommendations. These findings have also been demonstrated in the management of COPD. This leads to under- or over-treatment of patients and, in the case of COPD, to exacerbations and hospitalisations. These exacerbations are a significant clinical problem, affecting patient's lung function, quality of life and mortality. They are also a burden on the healthcare system. Technological advances in artificial intelligence offer the opportunity to address these issues in COPD management. In the past year, there have been remarkable innovations in the field of natural language processing, especially through large language models such as GPT-4 from OpenAI and Bard or Gemini from Google. These models offer an opportunity to improve the implementation of evidence-based care in clinical practice.

This study is a prospective, randomised trial that will compare therapy on discharge for patients with COPD. One arm will receive no intervention, while the other arm will receive a treatment recommendation from an LLM. The study will compare the percentage of patients treated according to the guideline.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Consent
* Discharge after hospitalization

Exclusion Criteria:

* Lack of Consent
Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery

The goal of this clinical trial is to compare frequency with postoperative nausea and vomiting in ASA( American Society of Anesthesiologists) I, II patients undergoing laparoscopic surgery.

The main question\[s\] it aims to answer are:

* Primary Outcome is the incidence of nausea and vomiting between 0-6 and 6-24 hours postoperatively and the need for additional antiemetics
* Secondary outcome is detection of additional analgesic needs and complications between 0-6 and 6-24 hours postoperatively.

Participants will receive aprepitant or granisetron for prevention of postoperative nausea and vomiting.

The aim of this study is to investigate the effectiveness of drugs used for postoperative nausea and vomiting in laparoscopic surgeries.

In the research; During the operation, the patient's vitals will be recorded intraoperative forms. Vitals are; heart rate, blood pressure, oxygen saturation, end tidal carbon dioxide levels; according to the pain level after awakening from the patient follow-up forms in the service.

The doses and times of analgesics will be screened, the frequencies of postoperative nausea, retching, vomiting, and additional antiemetic doses will be screened, respiratory depression, complications of anesthesia, arrhythmia, laryngospasm, hypo-hypertension, headache, dizziness, allergic reactions anxiety symptoms will be screened too.

we will try to emphasize which antiemetic is more effective than the other and which one has few side effects

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II patients patients undergoing laparoscopic surgery

Exclusion Criteria:

* ASA III and above patients who refused to participate in the study
CD180 Overexpression in Follicular Lymphoma

Background:Altered Toll-like receptor (TLR) expression levels and/or mutations in its signaling pathway (such as MyD88 mutation) contribute to the pathogenesis of lymphoproliferative disorders (LPD). CD180 is an orphan member of the TLR family that modulates the signaling of several TLRs, but only limited studies have evaluated its expression by flow cytometry (FCM) in LPD.

Methods: Using a multiparameter FCM approach, biologists have assessed CD180 mean fluorescence intensity (MFI) in lymph nodes (LNs) and peripheral blood (PB) samples obtained from patients with follicular lymphoma (FL; LN/PB, n=44/n=15), chronic lymphocytic leukemia (CLL, n=26/n=21), mantle cell lymphoma (MCL, n=13/n=17), and marginal zone lymphoma (MZL, n=16/n=12). Specimens from non-tumoral PB and LN (n=8/n=12) were used as controls.


Eligibility Criteria:
Inclusion Criteria:

* Samples from patients with:

  * LF: Follicular lymphoma
  * MCL: Mantle cell lymphoma
  * CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia
  * MZL : splenic marginal zone
  * Clt :control B-cells

Exclusion Criteria:

* Patient \<18 years old
Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease

The purpose of this feasibility study is to preliminarily evaluate the effects of Tai Chi - a mind-body exercise - on motor and cognitive function as well as quality of life in individuals recently diagnosed with Parkinson's disease (PD).

Specific Aim 1: To assess the feasibility of recruiting and retaining individuals with PD into a 6-month randomized controlled trial of Tai Chi exercise.

Specific Aim 2: To collect preliminary data on the efficacy of Tai Chi on improving gait and balance dynamics, physical and cognitive function, exercise activity, self-efficacy, mood, and quality of life in individuals with PD.

Eligibility Criteria:
Inclusion Criteria:

* Individuals recently diagnosed with idiopathic PD (≤ 10 years)
* Limited disease progression
* If taking PD-related medication, willingness to undergo baseline and follow-up testing while off medication
* Willingness to commit to the study protocols and complete Tai Chi program
* Willingness to be videotaped and audio-recorded during testing

Exclusion Criteria:

* Diagnosis of any form of atypical parkinsonism
* History of: stroke, head trauma, brain tumor, brain injury, seizures or other central nervous system condition, orthopedic impairment or other disease that could likely contribute to a gait disturbance or parkinsonism
* Any severe, chronic condition or acute medical event for which participation in exercise programs is contraindicated (e.g. debilitating Rheumatoid Arthritis, history of frequent falls, unhealed fracture)\*\*

  \*\* Unless the participant is able to obtain formal written approval from his/her treating physician granting permission to participate in our Tai Chi exercise program
* Participation in brain stimulation within the past 3 months
* Family history of seizures or unexplained loss of consciousness
* Current history of dementia or severe psychiatric illness. Patients with mild (non-suicidal) depression and/or anxiety may be included
* Acute illness requiring hospitalization within past 3 months
* History of deep brain stimulation or other brain surgery
* Participation in brain stimulation within the past 3 months
* Regular use of walking aid
* Significant Tai Chi experience (\> 6 months training in past 2 years)
Carbohydrates and Gut Hormones After Gastric Bypass Surgery

To investigate the secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1), after ingestion of glucose and fructose as separate monosaccharides or combined in the disaccharides sucrose and isomaltulose and the effect of acarbose in gastric bypass operated subjects and BMI-matched controls.

Disaccharides such as sucrose or isomaltulose (also called palatinose) require digestion into monosaccharides (both are digested to glucose and fructose) by enzymes located in the brush border of the small intestine to be absorbed. The study will investigate the influence of carbohydrate digestion on gut hormone secretion.

Eligibility Criteria:
Gastric bypass operated patients:

Inclusion Criteria:

* uncomplicated gastric bypass surgery performed minimum 12 months prior to study

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
* Pregnancy or breastfeeding
* Haemoglobin levels below 6,5 mM

Healthy control subjects:

Exclusion Criteria:

* Bariatric surgery or complicated upper abdominal surgery
* Pregnancy or breastfeeding
* Haemoglobin levels below 6,5 mM
* Co-morbidities or medicine significantly affecting glucose metabolism or appetite regulation
A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)

The purpose of this study is to investigate the safety and efficacy of an investigational treatment for Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 18 and 55 years of age (inclusive)
* Patient is an adult with a current DSM-IV diagnosis of ADHD of inattentive or combined subtype, as assessed via a structured interview using the ACDS and AISRS
* Females of child-bearing potential must use acceptable methods of birth control during the study and for 1 month post-therapy

Exclusion Criteria:

* Patient has a history of a neurological disorder resulting in ongoing impairment
* Patient has a lifetime history of a psychotic disorder, bipolar disorder, or post-traumatic stress disorder
* Patient has evidence of ongoing depression
* Patient is sensitive or allergic to methylphenidate
* Patient has glaucoma
* Patient has a previous history of narrowing or blockage of the GI tract
* Patient has a history of a sleep disorder (e.g., insomnia, sleep apnea, nightmares, or night terrors) within 6 months prior to screening
* Patient has a history of a cardiovascular disorder within 6 months prior to screening
* Patient has moderate or severe persistent asthma
* Patient has a history of substance abuse or dependence not in sustained full remission for at least one year according to DSM-IV
* Patient has taken part in a research study within the past 30 days of signing informed consent