cyrilzakka/clinical-trials huggingface dataset:
Pelvic Floor Dysfunction and Quality of Life in Patient Undergoing Gynecological Surgery

The purpose of the study is to assess the pelvic floor dysfunction and quality of life in patient undergoing gynecological surgery.Common gynecological surgeries done for prolapse, fibroids, and cervical abnormality and also for Gynecological cancer.Early physiotherapy after gynecological surgery improves recovery by managing pain, restoring movement, and strengthening muscles, especially the pelvic floor.Conservative treatments like pelvic floor muscle exercises, biofeedback, and lifestyle changes can help with pelvic symptoms, including urinary incontinence and mild to moderate prolapse.

This is a randomized control trial to see the effects of pelvic floor training on pelvic floor dysfunction and quality of life in patient undergoing gynecological surgery. Females meeting the inclusion and exclusion criteria will be divided into three groups by convenient sampling technique. A sample size of 48 females with 16 females in each group. Group A will be treated four weeks pre and 8 weeks post op pelvic floor training exercises, group B will be treated only 8 weeks post op pelvic floor training exercises and group C will receive basic post op nursing care. Group A and B will have three treatment sessions per week Assessment will be done at 0 week (1month prior to surgery), 1 day before surgery, 2nd , 4th, 6th and 8th week after surgery. Females will be screened by Pelvic organ distress inventory (PFDI-20) and Pelvic floor impact questionnaire (PFIQ-7).

Eligibility Criteria:
Inclusion Criteria:

* Women age:40 -60yrs
* undergoing vaginal or laparoscopic-assisted vaginal surgery for either POP repair (primary or recurrent), and/or hysterectomy

Exclusion Criteria:

* Emergency Surgery
* Chronic Illness
* Unstable Mental State
A Study Evaluating the Effectiveness of PEA Compared to Placebo for Reducing Pain Severity and Duration of Migraines.

This is a double-blind randomised controlled study to evaluate the effectiveness of orally-dosed Palmitoylethanolamide (PEA) compared to placebo for reducing pain severity and duration of migraines in otherwise healthy participants aged 18 years and older.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged over 18
* No recent history (within 2 years) of clinically significant medical conditions including, but not limited to, malignancy (and treatment for malignancy), cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled\*.
* Participant's full agreement and ability to consent to participation in the study
* At least 1 migraine (not headache) episode every 2 months as classified according to the International Classification of Headache Disorders, 3rd edition (ICHD3) for migraines published by the International Headache Society as detailed in section "Classification"
* Access to a computer or smartphone for completing online questionnaires and events.

Exclusion Criteria:

* Use of long-term medication (unless for controlled medical condition as above)
* Pregnant, trying to get pregnant or lactating women\^
* Chronic past and/or current alcohol use (greater than 14 alcoholic drinks week)
* Smokers
* Allergic or hypersensitive to any of the ingredients in the active or placebo formula
* Use of preventative migraine medication
* Migraines that have reported:

  * To occur on 15 or more days/month for more than 3 months, which, on at least 8 days/month, has the features of migraine headache.
  * A debilitating attack lasting for more than 72 hours.
  * A seizure

    * A medical condition will be considered uncontrolled if the participant reports ongoing treatment, a change of either medication type or dose in the past 3 months or any change in symptoms within the past 3 months.

      * Any person suspecting they may be pregnant (e.g. missed period, nausea, fatigue) will be directed to attend their GP for a pregnancy test prior to enrolment in the trial.
Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens

The purpose of the vaccination protocol is to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen.

vaccination protocol to induce clinically specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigens. Half of patients is treated with mRNA coding for Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. The other half of patients is treated with an individualized selection of mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is used as an adjuvants. Phase I/II clinical trial to analyse safety and immune responses in stage III/IV melanoma patients.

Eligibility Criteria:
Inclusion Criteria:

* malignant melanoma stage III/IV
* fresh frozen tumor tissue available
* informed consent given
* Karnofsky \>= 70%

Exclusion Criteria:

* brain metastasis
* parallel chemotherapy
* systemic treatment with glucocorticoids
* other malignancies
One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease

The primary objective is to determine the efficacy of rifaximin DR also referred to as Extended Intestinal Release (EIR) tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in participants presenting with active moderate Crohn's disease. A key secondary objective is to evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.

RECD3126 is a double-blind, placebo-controlled, parallel-group, multicenter, multiregional, 52-week study to assess the efficacy and safety of rifaximin DR tablets for the induction of clinical remission and endoscopic response at 16 weeks followed by clinical and endoscopic remission after 52 weeks of continuous therapy in participants with active moderate Crohn's disease.

Participants will be randomized in a 1:1 allocation to rifaximin or placebo at the beginning of the treatment period and will maintain treatment assignment throughout the duration of the study. Ileocolonoscopy will be performed on all participants at baseline, between Weeks 16 and 17 (end of the Induction Phase), and following completion of the 36-week Long Term Treatment Phase (Week 52).

Eligibility Criteria:
Major Inclusion Criteria:

* Moderate, non-fistulizing Crohn's disease in the ileum and/or colon prior to randomization; and a SES-CD score of ≥7 (confirmed by centralized endoscopy reading).
* During the screening period, the participant will need to have certain average daily scores for abdominal pain and average number of liquid/very soft stools.

Major Exclusion Criteria:

* Pregnant or lactating females. Females of childbearing (reproductive) potential must have a negative serum pregnancy test at screening and agree to use a highly effective method(s) of contraception throughout their participation in the study. Diagnosis of ulcerative or indeterminate colitis.
* Diagnosis of Celiac Disease.
* Bowel surgery within 12 weeks prior to screening and/or has surgery planned or deemed likely for Crohn's disease during the study period.
* Presence of an ileostomy or colostomy.
* Known fixed symptomatic stenosis/stricture of the small or large bowel.
* Had more than one segmental colonic resection.
* Had more than 3 small bowel resections or symptoms associated with short bowel syndrome.
* Current evidence of peritonitis.
* History or evidence of colonic mucosal dysplasia.
* History or evidence of adenomatous colonic polyps that have not been removed.
* Unwilling to be tapered off corticosteroids by Week 8 or the participant is known by the Investigator to be steroid-dependent.
* Has used a biologic within 12 weeks of randomization.
* Used cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or similar drugs within 8 weeks prior to randomization.
* Had rectal administration of 5-aminosalicylic acid (5-ASA) or corticosteroid enemas/foams/ suppositories within 2 weeks prior to screening visit.
An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained
* Children or adult patients treated with Norditropin® for an appropriate condition as prescribed by their physician

Exclusion Criteria:

* Patients not being treated with Norditropin®
* Patients who have discontinued treatment with Norditropin®
* Known or suspected allergy to Norditropin® or related products
* Contraindications for somatropin treatment consistent with the Prescribing Information for Norditropin®
Swedish Mammography Cohort

The Swedish Mammography Cohort began in 1987-1990, when 66,651 women living in two counties in central Sweden completed a mailed questionnaire that included items about their diet, parity, age at first child's birth, history of breast cancer in family, weight, height, and education. Follow-up questionnaires have been sent out in 1997 and in 2008-09.

From 1987 to 1990 a population-based mammography screening program was introduced in two counties in central Sweden. In Västmanland County all women born between 1917 and 1948 received a mailed invitation to be screened by mammography between March 1987 and March 1989 (n=41,786) together with a 6-page questionnaire; 31,735 women (76%) returned the completed questionnaires. In Uppsala County all women born between 1914 and 1948 were invited to the screening and received the same questionnaire between January 1988 and December 1990 (n=48517); 34916 women (72%) returned the completed questionnaires. Hence, questionnaires completed before undergoing mammography were obtained from 66,651 women (74%) in the source population. These questionnaires included items about diet, parity, age at first child's birth, history of breast cancer in family, weight, height, and education.

In 1997 a second questionnaire was sent to all cohort members who were still living in the study area. The questionnaire updated information about diet and was extended to include information on physical activity, medical history, age at menarche, history of oral contraceptive use, age at menopause, postmenopausal hormone use and lifestyle factors such as cigarette smoking history and use of dietary supplements. Majority of questions in the questionnaires have been validated.

During 2008-09, the exposure information was updated and extended by sending out two new questionnaires - one questionnaire on health including several signs of symptoms, sleeping, social relations etc (2008) and one on diet, dietary supplement use, and lifestyle factors (2009).

Incident cases of cancer are ascertained by record linkages of the study population with the National Swedish Cancer Register and the Regional Cancer Registers. Cardiovascular and other diseases as well as surgeries and causes of death are identified by linkage to the National Inpatient and other registries at the Swedish Board of Health and Welfare. Ascertainment of cancer cases and other diseases is almost 100% complete. Dates of deaths are ascertained through the Swedish Death Register (100% complete), and information on date of moving out of the study area is obtained by linkage with the Swedish Population Register.

Eligibility Criteria:
Inclusion Criteria:

* All women born between 1914 and 1948, living in central Sweden

Exclusion Criteria:

* None
Senile Osteoporotic Fractures Cohort Study（SOFCS）

Osteoporotic fracture is one of the main causes of disability and death in elderly patients. Specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. Investigators plan to collect and manage the baseline and clinical information of more than 2000 elderly patients with osteoporotic fractures after surgery through the platform of special disease collaborative prevention and treatment system and medical record database of Suzhou Municipal Hospital in two years, and carry out short-term and long-term follow-up observation.

Osteoporotic fracture is one of the main causes of disability and death in elderly patients. Compared with patients with no history of fractures, the risk of a second fracture after an initial fracture doubled, with a fatality rate of up to 34.8%. There has been a lot of progress in the diagnosis and treatment of osteoporotic fractures in the elderly. However, there are few reports on the diagnosis and treatment of osteoporotic fractures in the elderly after surgery. Based on previous studies, it is found that the re-fracture after operation of osteoporotic fracture in the elderly is not only directly caused by the fall, but also caused by the interaction of multiple risk factors including environmental factors, physiological factors and neuroskeletal musculoskeletal system. Therefore, it is of great significance to break the traditional diagnosis and treatment mode, improve the diagnosis and treatment effect, and save medical resources to carry out research on the disease characteristics, rules and risk warning after senile osteoporotic fracture operation. Specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. Investigators plan to collect and manage the baseline and clinical information of more than 2000 elderly patients with osteoporotic fractures after surgery through the platform of special disease collaborative prevention and treatment system and medical record database of Suzhou Municipal Hospital in two years, and carry out short-term and long-term follow-up observation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥65 years old
2. Patients with osteoporosis
3. No gender limitation

Exclusion Criteria:

1. \< 65 years old;
2. Non-osteoporotic fracture;
3. Alzheimer's disease;
4. Bone tumors.
Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light

The aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the changes of plasma NFL concentration in patients undergoing laparoscopic surgery with mild hypercapnia, and further explore its impact on the central nervous system.

Plasma NFL concentrations were measured preoperatively and 1 day postoperatively.

Secondary endpoints:CAM (Confusion Assessment Method) is conducted to check the subjects' baseline cognitive function preoperative day and 1 day postoperatively to assess whether delirium occurs.

Eligibility Criteria:
Inclusion Criteria:

* age over 60 years
* duration of pneumoperitoneum greater than 60 minutes
* American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ
* undergoing laparoscopic surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* history of mental or neurological disorders
* preoperative use of antipsychotic drugs
* American Society of Anesthesiology (ASA) status Ⅳ
* severe abnormalities in heart, lung, liver, kidney, and coagulation function
* Intracranial space-occupying lesions or major cerebrovascular diseases (such as carotid atherosclerosis and cerebral aneurysm)
* Severe hypertension or hypotension
* Severe metabolic acidosis or hypercapnic respiratory failure before surgery
Dose Ranging Study With LT, Monotherapy, PPAR

A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes


Eligibility Criteria:
Inclusion Criteria:

* 1. HbA1c \> 7.0% and ≤ 10.0% obtained at the Screening visit.
* 2. Men and women, 18-70 years of age Established Type 2 diabetes

Exclusion Criteria:

* 1. Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater than 10% weight loss during the last three months.
* 2. Administration of antihyperglycemic agents (other than thiazolidinediones) for more than three consecutive or a total of seven non-consecutive days during the four weeks prior to screening.
* 3. Administration of thiazolidinediones for more than three consecutive or a total of seven non-consecutive days during the six weeks prior to screening.
Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films

Abstract:

Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief, correction of nutritional status and improving the performance status. However, lack of standardization is the major obstacle for any scientific evaluation of any CAM trial. Mucositis is a major complication of irradiation in head and neck (H\&N) tumors, the addition of chemotherapy to irradiation may enhance this dose limiting problem. Licorice is a strong demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of this study was to compare the therapeutic safety and efficacy of T. and L. mucoadhesive films on oral mucositis in terms of pain control and/or ulcer treatment.

Methods and Materials: the study was a double-blind, randomized prospective trial of two types of mucoadhesive films in the management of oral mucositis occurred during head and neck cancer ( HNC ) radiotherapy. oral mucositis was assessed using a quantitative scale (WHO scales) and symptoms were assessed using visual analogue scales (VAS). 60 patients were enrolled in the study; there were 30 patients in the Triamcinolone (T) and 30 in the Licorice (L) group. In the T- group, patients received triamcinolone acetonide mucoadhesive films containing 1mg of the drug and patients in the L- group received licorice mucoadhesive films, an herbal agent. Data were collected at baseline, then twice a week for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* men and nonpregnant women
* women of childbearing age who were non-pregnant by pregnancy test and and using medically prescribed contraceptive
* no previous radiation therapy applied in the head and neck
* medically fit for a course of radical radiotherapy
* an ability to remain in the study for its entire duration

Exclusion Criteria:

* pregnant women
* women of childbearing potential in whom medically prescribed birth control was not used
* concurrent chemotherapy
* history of heavy alcohol or drug abuse judged to be important by the investigator - concomitant therapy with an investigational drug, or cancer chemo therapeutics or immunosuppressive medications
* sensitivity or intolerance to triamcinolone or licorice, lactose or similar formulations
* inability to provide informed consent
* actively bleeding gastric ulcer, severe esophageal reflux
* major surgery, trauma or burns in the preceding 4 weeks
* clinically significant hepatic, neurologic, endocrine, or other systemic disease-making implementation of the protocol or results difficult.
Follow-up After Metastasectomy in Patients With Kidney Cancer

This phase II trial studies the follow-up after metastasectomy in patients with kidney cancer. Following up patients' health condition after metastasectomy may help doctors to learn if the surgical removal of the primary tumor or the parts of the cancer that has spread to other parts of the body is a good method for treating patients who have kidney cancer.

PRIMARY OBJECTIVES:

I. To assess the 24-week progression free/relapse free survival rate in patients undergoing metastasectomy for metastatic renal cell carcinoma (mRCC).

SECONDARY OBJECTIVES:

I. To evaluate progression free survival (PFS), relapse free survival (RFS) and overall survival (OS) in patients undergoing metastasectomy.

II. To evaluate tissue determinants predictive for resectability, PFS and OS in patients undergoing metastasectomy.

OUTLINE:

After metastasectomy, patients are followed up every 6 months for up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed renal cell carcinoma (RCC)
* Patients have clinical reasons for undergoing a surgical resection of tumor; there are two main categories of patients:

  * Patients with fully resectable disease as defined by lesions accessible by a surgeon during no more than two separate surgical sessions, and are expected to be rendered surgically no evidence of disease (NED)
  * Patients undergoing a noncurative procedure for relief of symptoms or for management of threatening lesions
* Patients have been deemed resectable by the subspecialty surgeon involved in the patient's care
* Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy; the only approved consent is attached to this protocol
* Patients must have ability to comply with study and/or follow-up procedures
* Members of all races and ethnic groups are eligible for this trial

Exclusion Criteria:

* Patients must not have active acute infections that could be worsened by surgery or interfere with this study
* Patients must not have clinically significant cardiovascular disease, or peripheral vascular disease that creates an unacceptably high operative risk
* Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates surgical resection, or render the subject at high risk from treatment complications
* Patients must not have a history of uncontrolled severe depression