cyrilzakka/clinical-trials huggingface dataset:
Effects of Reflexology on Postpartum Pain, Fatigue, Sleep Quality and Lactation

The aim of this research is to determine the effect of foot reflexology applied to primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep quality and lactation. This research is a randomized controlled trial. The study was conducted in Şanlıurfa, which has the highest fertility rate in Turkey.

The aim of this research is to determine the effect of foot reflexology applied to primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep quality and lactation. This research is a randomized controlled trial. The study was conducted in Şanlıurfa, which has the highest fertility rate in Turkey. The sample of the research consisted of 80 primiparous women (reflexology group: 40 and control group: 40). The data were collected between 01 January 2020 - 31 January 2021. "Introductory Information Form", "Visual Analogue Scale" for Pain, "Visual Analog Scale for Fatigue", "Pittsburg Sleep Quality Index" and "Bristol Breastfeeding Assessment Tool" were used as data collection tools. Foot reflexology was applied to the experimental group for 40 minutes (left foot 20 minutes and right foot 20 minutes) once a week for postpartum 8 weeks. The control group was only watched. In the intergroup comparison of the experimental and control groups, chi-square for categorical variables and independent groups t-test for numerical variables were used. Two-way repeated measures ANOVA test was performed in terms of time and group interaction in repeated measurements

Eligibility Criteria:
Inclusion Criteria:

* Caesarean section,
* Primipary,
* 19 and over and under 35
* Literate,
* 37 and above pregnancy week
* Giving birth singularly,
* Having spinal anesthesia
* No chronic disease or pregnancy complication,
* Have no breast-related health problems
* Have not had an operation related to the breast,
* Women who do not have any health problems in the feet of the mothers in the treatment group

Exclusion Criteria:

* The baby has died or is not present,
* Multiparous,
* Women with health problems in their feet
Anticoagulant and Antiplatelet Agents in Patients Undergoing Vitreoretinal Surgery

Purpose: To establish the prevalence of anticoagulant, aspirin, and clopidogrel use in patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar anesthesia between users and non-users.


Eligibility Criteria:
Inclusion Criteria:

* Take or no anticoagulant treatment before surgery,
* Vitreoretinal surgery

Exclusion Criteria:none

* No surgery
* Anesthetic complication
Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

Patients with recurrent or refractory solid tumors or brain tumors that are unresponsive to conventional therapy, or with no known effective therapy, will be treated. Experiments in the laboratory have shown the experimental drug RAD001C (RAD001, Everolimus) can prevent cells from multiplying. RAD001 is now being tested in diseases such as cancer, in which excessive cell multiplication needs to be stopped. The drug has been tested in adult cancer patients and has been well tolerated by subjects in these studies. It is experimental and, therefore, available in clinical trials.

Although a Phase II portion of this study was planned, it was never initiated.

Eligibility Criteria:
Inclusion Criteria:

* Adequate performance status
* Adequate bone marrow, kidney, heart, and liver function

Exclusion Criteria:

* Must not be receiving concomitant anti-cancer treatment
* Must not be pregnant
Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity

Phenotypic characterization of patients with Hu-Abs, including the different neurological presentation and the presence or not of an underlying cancer.

Analysis and clinical correlation of the diagnostic techniques for Hu-Abs detection (immunofluorescence, immunodot/Western blot, and CBA) in serum and/or CSF.

Genomic and transcriptomic features of tumors (histological and immune infiltrate characteristics, transcriptomic profile, mutational status).


Eligibility Criteria:
* Inclusion Criteria \* :

  * Patient with neurological disorder
  * Patient with Hu antibody in sera or CSF
* Exclusion Criteria \* :

  * Patient with no data
  * Patient without neurological disorder
  * Patient without Hu antibody in sera/CSF
More Sleep: Pain Response to Longer Sleep

This study is being done to find out whether extending sleep for at least an hour per night, seven days a week, predicts a higher tolerance and a higher threshold for pain. This is a 21-day study. Participants will be asked to wear sleep- and heart- monitoring watches. Pressure pain and cold pain will be measured at study visits.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 24 (inclusive) years of age at enrollment
2. Fluent English speaker and reader
3. Willing to refrain from initiating new therapeutic interventions (e.g., medication; behavioral) designed to target sleep or pain for the duration of study participation

Exclusion Criteria:

1. Diagnosed with a sleep disorder
2. Diagnosed with a pain disorder
3. Has experienced a cold-related injury frostbite or has any other nerve damage to the feet
4. Has a history of injury to any of the muscular measurement sites for pain (I.e. shoulder, jaw, forearm)
5. Diagnosed with hypertension or cardiovascular disease
6. Evidence of hypertension
7. Diagnosed serious mental health disorder or substance use disorder
8. Taking any physician-directed pharmacologic intervention for sleep
9. Taking any physician-directed pharmacologic intervention for pain
10. Personal health history of traumatic brain injury
11. Pregnant
12. Current smoker
Efficacy and Safety of ASF1057 in the Treatment of Seborrhoeic Dermatitis

A growing body of evidence supports the hypothesis that the pathophysiology of seborrhoeic dermatitis has a potentially causative neurogenic inflammatory aspect. ASF1057 is a new drug that acts through a modulation of neurogenic inflammation through important complementary mechanisms of action. This study will test the efficacy and safety of ASF1057 in the treatment of patients with seborrhoeic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of moderate to severe seborrhoeic dermatitis

Exclusion Criteria:

* Other active skin diseases
* Use of certain systemic and topical treatments
* Extensive sun exposure
Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome

The aim of this study is to compare the efficacy of calcium gluconate infusion versus cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who are at high risk for OHSS.

Ovarian hyperstimulation syndrome (OHSS) is a serious complication of assisted reproduction.

Previous studies revealed that calcium gluconate infusion reduced the risk of OHSS. Other studies revealed that cabergoline (potent dopamine receptor agonist on D2 receptors)was effective in preventing OHSS.

The aim of this study is to compare the efficacy of calcium gluconate infusion versus cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who are at high risk for OHSS.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are stimulated using the long luteal GnRH agonist protocol and at high risk for developing OHSS \[have more than 18 follicles (\> 11mm) and serum estradiol ≥ 3000 pg/ml on the day of HCG administration\].

Exclusion Criteria:

* Fibrosis of lung
* Swelling or inflammation around the heart or lung
* Hypertension
* Liver disease
* Heart valve disease and allergy to cabergoline or ergot derivatives.
Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease

Some studies have shown that rifaximin is effective in the management of Crohn's Disease. Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study to assess the effect of rifaximin combined with thiopurine on preventing postoperative endoscopic recurrence in Crohn's disease, compared with thiopurine. The primary endpoint is the rate of endoscopic recurrence at 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients with Crohn's disease undergoing intestinal resection of all macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis;
2. Enrolled patients must have one or more risk factor for the development of postoperative recurrence including penetrating disease behaviour, prior bowel resection, and active smoking.

Exclusion Criteria:

1. Severe comorbidities;
2. With a stoma;
3. With malignancy;
4. Pregnancy;
5. Intolerant of thiopurine drugs;
6. With contraindication of using rifaximin or thiopurine drugs.
Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer

Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

A randomised controlled trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Eligibility Criteria:
Inclusion Criteria:

* female ≥ 18 years old ECOG 0-2

Exclusion Criteria:

* brain metastasis
Yakima Head Start Fluoride Varnish Study

The aim of this study is to determine whether an annual application of three (3) fluoride varnish doses over two weeks is at least as effective in reducing cavities as the current semi-annual application.

The study population will consist of pre-school aged children who are residents of Yakima County, in central Washington State. Children will be recruited from non-migrant Head Start programs for ethnic minority farmworker children in the Yakima Valley.

This study will be a randomized, double blinded trial with one experimental and one standard treatment group. Each participant will be randomly assigned to one of two study groups. The participant and the personnel conducting the study will not know to which study group the participant was assigned.

This trial has two study groups:

1. Massive Dose (Experimental):

   Annually for three years, children in the experimental group will receive three .30ml applications of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni), followed 6 months later by three .30ml applications of placebo varnish in two weeks. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually.
2. Semiannual Dose (Standard):

Annually for three years, children in the standard treatment group will receive one .30ml application of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni) and two .30ml applications of placebo varnish in two weeks. They will receive this regimen again 6 months later. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually.

Both the experimental and standard treatment children will receive basic restorative dental care on decayed surfaces only, as well as toothbrushes for the duration of the study period. Parents will fill out questionnaires about behaviors such as diet, hygiene and prior dental care. Results will inform future treatment regimens for high-caries-risk populations.

Eligibility Criteria:
Inclusion Criteria:

* Age 36-71 months
* Enrolled in participating Head Start Center
* Plan to stay in Yakima County for duration of the study
* One sound tooth surface present

Exclusion Criteria:

* No teeth present
* Developmentally unable to give oral assent
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)

This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy, participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, CD20+ DLBCL or CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2 or 3a, according to the World Health Organization (WHO) classification system
* Currently being treated with rituximab intravenously (IV) in the Induction or Maintenance period, having received at least one full dose of rituximab IV, defined as standard full dose of rituximab IV 375 milligrams per square-meter (mg/m\^2) administered without interruption or early discontinuation (i.e. tolerability issues)
* Expectation and current ability for the participant to receive at least 4 additional cycles of treatment during the Induction period or 6 additional cycles of treatment during the Maintenance period (participants with follicular NHL)
* An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion greater than or equal to (\>=) 7.5 centimeters (cm), or Follicular Lymphoma International Prognostic Index (FLIPI) (low, intermediate or high risk) assessed before the first rituximab IV administration in Induction period
* At least one bi-dimensionally measurable lesion defined as \>=1.5 cm in its largest dimension on computed tomography (CT) scan
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 3

Exclusion Criteria:

* Transformed lymphoma or FL IIIB
* Primary central nervous system lymphoma, histologic evidence of transformation to a Burkitt lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, or primary cutaneous DLBCL
* History of other malignancy
* Ongoing corticosteroid use greater than (\>) 30 milligrams per day (mg/day) of prednisone or equivalent
* Inadequate renal, hematologic, or hepatic function
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
* Contraindications to any of the individual components of standard chemotherapy
* Other serious underlying medical conditions, which, in the Investigator's judgement, could impair the ability of the participant to participate in the study
* Recent major surgery (within 4 weeks prior to dosing, other than for diagnosis)
* Active hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or human immunodeficiency virus (HIV) infection
Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

This is a randomized, placebo-controlled, multi-center, double-blinded, Phase III study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.


Eligibility Criteria:
Patients must fulfill all of the following inclusion criteria to be eligible for enrollment in this study:

1. Histologically confirmed locally advanced (T1N1-3M0 or T2-3N0-3M0) squamous cell carcinoma of the thoracic esophagus (per the 8th Edition of UICC-TNM Classification);
2. No suspicious cervical lymph node metastasis on cervical contrast-enhanced CT; no systemic metastasis from radiological examination;
3. Expected to be achievable to conduct R0 resection.

Patients must not enter this study if any of the following exclusion criteria is fulfilled:

1. Having malignant tumors other than esophageal carcinoma within 5 years prior to randomization;
2. Combined with other inoperable condition;
3. Previous serious allergy to chemotherapeutic agents (paclitaxel or cisplatin) or any monoclonal antibody;
4. Combined with other conditions unsuitable for participation in this study as judged by investigators.

Other protocol defined Inclusion/exclusion criteria could apply.
Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine

The primary objective of this study is to characterize the antibody response to seasonal influenza vaccine, in patients with active RRMS, treated with cladribine, compared to control individuals with basic immunomodulatory treatment. Serum antibody titers against the respective pathogen will be assessed prior to and 6 to 8 months following vaccination.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form (ICF)
2. Age 18 to 60 years old (inclusive) as of the date the ICF is signed
3. Diagnosis of RRMS according to the revised McDonald criteria
4. EDSS score of 0.0 to 7.0 (inclusive)
5. In case of participants who are subjected to influenza vaccination by the treating physicians prior to cladribine the first or second cycle of cladribine (cohort 1 + cohort 3), this should be performed at least 4 to 6 weeks before the start of cladribine.

Definition of control group:

Patients with active RRMS treated with cladribine will be compared to sex and age matched control individuals, with RRMS under basic treatment either with interferon beta, glatiramer acetate, dimethyl fumarate or teriflunomide, who provide sample material prior to and 6 to 8 months after routine seasonal influenza vaccination during the same period.

Exclusion Criteria:

1. Previous treatment with B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
2. Any previous treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
3. Medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, or to complete the study
4. Patients that receive immunosuppressive treatment for diseases other than MS or that receive long-term corticosteroid treatment
5. Patients that received apheresis procedures 6 weeks prior to vaccination or in-between vaccination and DMT initiation
6. Systemic high dose corticosteroid therapy within 6 weeks prior to vaccination or in-between vaccination and DMT initiation
7. Patients with verified infection by human-immunodeficiency-virus or hepatitis-c-virus
8. Patients with major impairment of the blood coagulation system including therapy with anticoagulants
9. Patients with known chicken egg allergy
Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)

The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Be a male or female between the ages of 18 and 65 years, inclusive
* Female subjects must be either surgically sterile or at least 2 years postmenopausal
* Have a BMI of 27 - 38.9, inclusive
* Have a stable weight for the past 30 days per subject report
* Be otherwise healthy and have an acceptable medical history
* Have negative urinalysis test results for drugs of abuse and alcohol
* Have the ability to understand the requirements of the study, have provided written informed consent and agree to abide by the study restrictions
* Exhibit stable behavior patterns with regard to smoking and exercise
* Subject who has at least one factor of the metabolic syndrome

Exclusion Criteria:

* Be pregnant or nursing
* Have taken exclusionary medication in the past 30 days
* Have any clinically significant abnormal laboratory test as determined by the investigator
* Have a clinically significant illness during the 30 days before enrollment
* Have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV
* Have a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer
* Have a previous diagnosis of diabetes
* Be otherwise unsuitable for the study, in the opinion of the investigator
* Have an allergy to safflower seeds or its byproducts (e.g., safflower oil)
* Have any postmenopausal bleeding within the last 6 months
* Have been involved in a formal or informal (self-imposed) diet regimen within the last 30 days
* Currently working night shifts
* Have a history of known multiple miscarriages
HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy

The purpose of this study is to compare the level of cleanliness using the HyGIeaCare Prep vs the standard of care Split-dose PEG prep used prior to colonoscopy.

The level of cleanliness will be recorded using the Boston Bowel Prep Score (BBPS) by an endoscopist who is blind to the randomized preparation.

Eligibility Criteria:
Inclusion Criteria:

1. Patient referred to colonoscopy
2. Patient with high probability for poor prep due to one or more of the following:

   1. Chronic constipation (Rome III functional constipation criteria)
   2. Gastroparesis
   3. Immobilization
   4. Diabetes
   5. History of poor prep

Exclusion Criteria:

1. Patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study.
2. Patient is currently taking narcotics.
3. Patient has any of the contraindications listed below:

   1. Cardiac: Congestive heart failure (NYHA class III or IV or EF \< 50%)
   2. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery
   3. GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
   4. Abdominal surgery within the last 6 months
   5. Pregnancy