cyrilzakka/clinical-trials huggingface dataset:
Effect of Foot Reflexology on Blood Pressure and Pulse Rate: A Randomized Clinical Trial

Hypertension (HT) has been known for its prominent risk of cardiovascular events. Although there are various pharmacological choices, many patients fail to adhere with them. Therefore, adjunctive non-pharmacological treatment is a promising approach. Foot Reflexology is one of a complementary therapies that has been proved for its ability to decrease blood pressure (BP), however, there is limited data in patients with stage-2 HT. We aimed to examine the effectiveness of foot reflexology as adjunctive therapy for BP lowering. This was a single-center randomized clinical trial. Hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). Foot reflexology was performed in the intervention group during a clinical visit. Office BP and pulse rate (PR) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.

Background Hypertension (HT) has been known for its prominent risk of cardiovascular events. Although there are various pharmacological choices, many patients fail to adhere to them. Therefore, adjunctive non-pharmacological treatment is a promising approach. Foot Reflexology is one of the complementary therapies that has been proved for its ability to decrease blood pressure (BP), however, there is limited data in patients with stage-2 HT.

Objective To examine the effectiveness of foot reflexology as adjunctive therapy for BP lowering.

Methods This was a single-center randomized clinical trial. Hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). Foot reflexology was performed in the intervention group during a clinical visit. Office BP and pulse rate (PR) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed stage-2 HT (defined by office SBP≥140 mmHg and/or DBP ≥90 mmHg at first hospital visit)
* On stable anti-HT drugs for at least 3 months before enrollment.

Exclusion Criteria:

* Pregnant women
* History of foot surgery or bone fracture
* Skin disease of the foot
* Diabetes neuropathy
The CSTME Associates With the Prognosis of Stage II and III Colorectal Cancer

Colorectal cancer (CRC) is the second most commonly occurring cancer worldwide. Thirty-five percent of CRC patients are diagnosed at stage II/III, and their outcome differs even if they are in the same stage. Previous study found that the microenvironmental collagen is associated with tumor progression and metastasis. Whether tumor microenvironmental collagen signature is associated with colorectal cancer prognosis still remains unknown. We hypothesize that the tumor microenvironmental collagen signature of colorectal cancer is associated with prognosis.

Colorectal cancer (CRC) is the second most commonly occurring cancer worldwide. Thirty-five percent of CRC patients are diagnosed at stage II/III, and their outcome differs even if they are in the same stage. In the "seed and soil" theory proposed by Stephen Paget, tumor cells play the role of the "seed", and the tumor microenvironment (TME) is the "soil". TNM classification provides useful but uncomplete prognosis information in colorectal cancer. It lacks the assessment of the "soil" signature of tumor microenvironment. Previous study found that the microenvironmental collagen is associated with tumor progression and metastasis. Whether tumor microenvironmental collagen signature is associated with colorectal cancer prognosis still remains unknown.

This study is a retrospective observational study performed in two centers. The main purpose of this study was to investigate whether the tumor microenvironment collagen signature (CSTME) can discriminate the 5-year DFS of stage II/III CRC patients, the secondary purpose is to compare the AUC (area under the receiver operating characteristic curve) of TNM stage+CSTME in predicting 5-year DFS with that of TNM stage alone. This study would introduce the tumor microenvironmental collagen signature into current colorectal cancer classification system, which would provide reference for clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed with colorectal cancer
* TNM stages II and III (according to the 8th edition of AJCC Cancer Staging Manual)
* Received radical tumor resection surgery

Exclusion Criteria:

* ASA grade 4
* Preoperative radiotherapy and/or chemotherapy
* Hereditary colorectal cancer
* Pregnancy
Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.

Eligibility Criteria:
Inclusion Criteria:

* Open angle glaucoma

Exclusion Criteria:

* Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders.
* Functionally significant visual field loss, including severe nerve fiber bundle defects.
* Prior glaucoma surgery.
* Uncontrolled systemic disease, pregnant females or those planning a pregnancy.
* Other ocular status conditions, etc.
Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection

The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor.

The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years
2. Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Up to 3 prior treatment regimens
5. Meet all eligibility requirements for autologous transplant
6. Adequate marrow function defined as white blood cells (WBC) \>3,000; ANC \>1,500/mm3; platelets \>75,000/mm3
7. Adequate renal function defined as creatinine clearance \> 30 mL/min by Cockcroft-Gault
8. Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin \< 2 times upper limit of normal
9. Able to provide informed consent
10. Women not pregnant and agree to use contraception

Exclusion Criteria:

1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
2. Brain metastases or carcinomatous meningitis
3. Previous treatment with high dose chemotherapy and autologous transplant
4. Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors
5. Acute infection or unexplained fever \>38°C
6. Weight \> 175% of ideal body weight as defined by the Devine equation
7. Experimental therapy within 4 weeks
8. Cytokine administration in the previous 14 days
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of KBP-5074.


Eligibility Criteria:
Key Inclusion Criteria:

1. Males or females, of any race, between 18 and 80 years of age, inclusive, at screening.
2. Body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
3. Subjects with normal hepatic function must be in good health.
4. Subjects must meet the criteria for moderate hepatic impairment based on Child Pugh B.

Key Exclusion Criteria:

1. Significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study.
2. Positive serology test results for hepatitis B surface antigen and/or human immunodeficiency virus 1/2.
3. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to dosing, whichever is longer.
4. Use of mineralocorticoids or MRAs (eg, spironolactone or eplenerone) within 90 days prior to study drug administration, unless deemed acceptable by the medical monitor and sponsor.
5. Subject has used prescription drugs within 30 days of study drug administration, with the exception of established therapy for hepatic disease and the treatment of associated disorders that have been stable for at least 30 days before study drug administration, as approved by the investigator and in consultation with the medical monitor.
The LYSA (Linking You to Support and Advice) Trial

This study's aim is to evaluate the feasibility of introducing a women's malignancy survivorship clinic incorporating symptom management through ePRO collection (complex intervention) into routine follow up care in patients with early-stage Hormone Receptor(HR)-positive breast and gynaecologic cancer post primary curative therapy.

Study Design: Complex interventional study. Specific Aims: To evaluate the feasibility of introducing a women's malignancy survivorship clinic in Ireland incorporating symptom management through electronic Patient Reported Outcomes (ePROs) collection (complex intervention) into routine follow-up care in patients with early-stage HR-positive breast and gynecologic cancer post-primary therapy.

Sampling Method: Randomized Control Design (Parallel Arms). Sample Size: 200.

Entry Criteria: Women with early-stage breast/gynecologic cancer within 12 months of completion of primary curative therapy:

* Breast cancer: Stage I-III hormone receptor-positive (defined as estrogen receptor and/or progesterone receptor ≥ 1%) and HER2-negative per ASCO-CAP guidelines on or recommended to commence adjuvant endocrine therapy during the study period.
* Cervical cancer: Stage I to III treated with curative intent.
* Endometrial cancer: treated with curative intent adjuvant radiotherapy +/- chemotherapy

Eligibility Criteria:
Inclusion Criteria:

1. Women aged \> or = 18 years.
2. Ability to read and understand English.
3. Access to internet.
4. Early-stage breast/gynaecologic cancer within 12 months of completion of primary curative therapy:

   * Breast cancer: Stage I-III hormone receptor-positive (defined as estrogen receptor and/or progesterone receptor ≥ 1%) and HER2-negative per ASCO-CAP guidelines on or recommended to commence adjuvant endocrine therapy during the study period.
   * Cervical cancer: Stage I to III treated with curative intent.
   * Endometrial cancer: treated with curative intent adjuvant radiotherapy +/- chemotherapy

Exclusion Criteria:

1. Patients who are not treated with curative intent as above.
2. Patients with premalignant disease.
3. Persons who, in the opinion of the researcher or supervising clinician, are unable to cooperate adequately with the study protocol.
4. Recent (within 12 months) participation in a study/programme involving a lifestyle intervention (e.g diet, exercise, survivorship). Note: Per discretion of PI as to whether may impact the outcome of this study intervention.
A (5-5-5-8) Technique for Laparoscopic Cholecystectomy

The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.

More than 50 different LC procedures are described in the literature, mostly as a result of changes made by surgeons to enhance cosmetic and postoperative results. Some adjustments include port size and/or number reductions relative to conventional LC usage. Each of these methods has benefits and drawbacks, and each one is appropriate for usage in particular circumstances.

The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.

The study has two analyses:

1. at 6 month follow up
2. at 24 months follow up

Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years
* Patients eligible for LC during the study period

Exclusion Criteria:

* refused to participate
Platelet Modulation: A Study of Angiogenic and Coagulation Proteins in Patients With Cancer

Blood samples on persons with cancer will be sampled for angiogenic, metastatic and coagulation proteins.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of malignancy

Exclusion Criteria:

* Patients taking aspirin, NSAIDs, warfarin or platelet inhibitor therapy
Dietary Influence on Serotonin in Cognitive and Emotional Functioning in Women

The purpose of this study is to determine whether a chronic dose of a tryptophan-rich protein drink (lumiVida™) can improve cognitive function, emotional processing and sleep in middle-aged women. In addition, also genetic predictors of susceptibility to an increase of Trp levels will be investigated.

lumiVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. The investigators do not claim that this supplement is meant to treat any ailment

The treatment conditions are either placebo or lumiVida™ (N=30 per group) 0.5 g twice a day (total 1 g/ day). The first testing took place on the screening day (baseline). Subsequently, participants were supplied with supplements for 19 days intervention (sachets which had to be dissolved in 200-ml water). After 19 days, participants were tested again (same tests as on the baseline day). An additional facet was the completion of a 'sleep diary', which asks questions about sleep quality and latency, and bed-time mood, as well as allowing recording of timing of supplement taking.

Eligibility Criteria:
Inclusion Criteria:

* Physically and mentally healthy (defined by not concurrently receiving medical/pharmacological treatment (except mild painkillers), free of gastrointestinal complaints, not in pain, not diagnosed with a psychiatric disorder
* Female
* Aged: 45 - 65 years

Exclusion Criteria:

* Having received treatment in the last 12 months for: depression, anxiety, neurological disease including migraine, dementia, epilepsy, Parkinson's.
* History of any psychiatric or neurological illness in the last 2 years.
* Current medication targeting the brain (except mild painkillers, e.g. pure paracetamol, ibuprofen), including steroids, e.g. for contraception, Hormone Replacement Therapy (HRT), drugs for weight control, stimulants (e.g. phenylephrine, ephedrine), antihistamines, and some herbal or nutritional remedies including St. John's Wort, 5-hydroxy-tryptophan, or melatonin (which can affect the serotonin system).
* Pregnancy
* Current gastrointestinal complaints
* Diabetes (Type 1 or 2)
* Body mass index \< 18 or \> 35
Contrast-enhanced MRI in Children 2 Months to <2 Years

The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to \< 2 years of age

Safety issues are addressed in the AE section

Eligibility Criteria:
Inclusion Criteria:

* Age: 2 months to \< 2 years (23 months)
* Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI
* Able to comply with the study procedures

Exclusion Criteria:

* Clinical unstable participants (eg, intensive care unit)
* Renal Insufficiency
* Participants undergoing chemotherapy \</= 48 hours prior to and up to 24 hours after the administration of Magnevist.
The Effect of Botulinum Toxin Injection After Hemorrhoidectomy in Pain Control.

Hemorrhoids are a common disease in the general population. Its prevalence is estimated to be 5-36 % and more prevalent in western countries . Half of people older than 50 years of age will suffer from hemorrhoids in a period of their life, of which only 5-10% will require surgical intervention while most of the remainders become asymptomatic and improved with the conservative treatment.

Conservative treatment in the form of diet modification as well as some medical treatment, is usually effective. On the other hand, a few patients require surgical intervention. Surgery is indicated for those not responding to conservative management, those with grade III, and grade IV hemorrhoids.

Surgical treatment is the only curative method for hemorrhoidal disease and indicated for advanced and complicated disease. The most radical operations with the best results are the Milligan-Morgan and Ferguson hemorrhoidectomy .

However, the major concern of hemorrhoidectomy is the post-operative pain that occurs in 20-40 % of patients and it is considered the main cause of refusing surgery. The cause of postoperative pain is multifactorial, including the type of anesthesia , hemorrhoidectomy technique. and spasm of the internal anal sphincter (IAS) that becomes exposed after hemorrhoidectomy. The spasm of the IAS is considered the target to relieve pain post operatively. Lateral internal sphincterotomy (LIS) is widely used as an adjunct to relieve pain post hemorrhoidectomy as it release the spasm of the sphincter and subsequently relieve pain. However, this procedure is not accepted by many surgeons due to its recorded complications as bleeding and mild degree of fecal incontinence, so its role following hemorrhoidectomy is still controversial.

On the other hand, the spasm of the anal sphincter can be abolished by injection of the botulinum toxin which acts on the acetylcholine receptor and consequently temporary muscle paralysis occurs that is followed by decreased pain and wound healing.

Our hypothesis is botulinum toxin relaxes the internal sphincter, so prevent its spasm and so reducing the pain and promoting wound healing more rapidly.

many procedures have been described to decrease the pain post hemorridectomy. Internal sphincterotomy Botox Injection giving strong analgesics

We aim to evaluate the efficacy of Botox and internal sphincterotomy in pain relief after hemorridectomy.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes,
* aged between 18 and 70 years old.
* Grade III and IV hemorrhoids.
* Those with failed conservative treatment.

Exclusion Criteria:

* surgically unfit patients due to multiple comorbidities,
* patients who need emergency operation for complicated hemorrhoids,
* patients with partial rectal prolapse
* patients with rectal varices due to portal hypertension
Probiotic for Pain Osteoarthritis

Many people with symptomatic Osteoarthritis (OA) report chronic joint pain, especially if those patients are older than 50 years. In Europe OA is the most common form of chronic pain condition (34%) reported and entails a high economic and social burden for society. Probiotic treatment has been shown to promote bone metabolism, reduce pain and inflammatory responses of age-related musculoskeletal disorders, including OA. Gut microbiota has been proven to be of crucial importance in maintaining human health. However, the microbiota profile changes with aging, while the loss of microbiota diversity and the alterations in the optimal composition and quantity of beneficial microbes are believed to increase the risk of many diseases. Interestingly, emerging evidence leads to the hypothesis that alterations in the gut microbiome could also be considered as possible triggering factors in the onset of musculoskeletal disorders such as OA. We hypothesize that these patients with pain-OA will demonstrate an alteration of the gut microbiota to associated with the intensity of pain.


Eligibility Criteria:
Inclusion Criteria:

* All subjects will have hip or knee OA according on radiographic findings (Kellgren-Lawrence scale ≥3) and who require and eligible for chronic, daily therapy with an NSAIDs to control OA sign and symptoms. A physiatrist (physician) will establish the diagnosis of pain-OA.

Exclusion Criteria:

* Psychiatric or neurological disorders, celiac disease, lactose intolerance, or allergies or other ongoing illnesses (i.e., irritable bowel syndrome, diabetes, ulcerative colitis, etc.) or recent antibiotic treatment (i.e., \<3 months before the beginning of the study).
* Participants with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
* Participants require treatment with aspirin \> 325 mg /day.
* Participants who smoked more than 10 cigarettes per day were excluded.
* Participants will be excluded also if they score greater than 6 points on the Beck Depression Inventory (BDI) or more than 30 points in the State Trait Anxiety Inventory (STAI), dementia and not Italian speaking due to the high level of language skills required for questionnaires and quantitative sensory testing.
* Post-traumatic OA (e.g., fractures), congenital hip deformities, surgical interventions to the hip or knee, Legg-Calvé-Perthes disease, or degenerative or non-degenerative neurological conditions in which pain perception is altered will be excluded