cyrilzakka/clinical-trials huggingface dataset:
Effect of Aerobic Exercise on Premenstrual Syndrome Symptoms (PMS).

To Determine the Effect of Regular Aerobic Exercise Training on Severity of Premenstrual Syndrome Symptoms and Health-Related Quality of life on working women.Exercise can be used as an alternative therapy in reducing premenstrual symptoms.But still there is lack of Literature on PMS in work Place and effect of Treatments to improve overall Quality of life in working women.And this study aims to fill the gap by assessing the impact that Premenstrual Syndrome can have on working women's Quality of life and can be used to establish a model of regular exercise program with the potential to decrease premenstrual symptoms and improve quality of life for a menstrual health-friendly workplace environment for Female Employees.

A review conducted to assess the effect of 8 weeks of aerobic exercise on the non-athletic females facing premenstrual syndrome symptoms. The results displayed positive effects of 8 weeks of exercise on symptoms of PMS. The aerobic exercise helped to reduce both psychological and physical symptoms.

Regular swimming for 8 weeks also decreased the severity of PMS symptoms in females. Results deduced that the exercise improved the vascular activity of the heart, and reduced stress and anxiety. Moreover, it also enhanced bone density.

In one of RCT the effect of 3 months of exercise through treadmill on PMS and hormones was also evaluated. It was assumed that many symptoms of PMS were reduced including the carbohydrate cravings, stress, and depression. The electrolyte change was also reduced. Exercise also reduced the proportion of backache and menstrual cramps in females.

Another review on a balanced diet and regular exercise demonstrated that the diet rich in the essential nutrients and regular exercise improved the health of the females. The symptoms of PMS were also reduced in these females along with the intensity of dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Regular menstrual cycles (cycles of 21-35days with a bleeding time of 3-10days).
* PMS (as per screening questionnaire PSST Criteria).
* No history of psychiatric disorder (Score below 40 from Beck Depression questionnaire).
* Women working in hospital settings (health care Professionals).

Exclusion Criteria:

* No history of co-existing Medical illness including DM, Thyroid dysfunction, Hypoglycemia, Cardiac Pathologies.
* Women undergone Hysterectomy or other Gynecological procedure.
* Women on medications i.e. Contraceptive pills and HRT.
* Pregnant women.
* History of drug abuse or Alcohol intake.
* Participation in another sports program
Acute Abdomen in Adults- a Prospective Study on Emergency Department Admissions

This is a non-randomized, prospective, population-based, single-center study designed to evaluate conditions resulting emergency admission in patients with abdominal pain. Furthermore, we are interested in how many patients are discharged with "non-specific abdominal pain" but later readmitted and diagnosed with a specific diagnosis.

1000 adult patients with acute abdominal pain will be recruited at Tampere University Hospital Emergency department. The patients will fill in a questionaire about the symptoms and their duration. A urine sample will be collected for polyamine molecule analysis with an electronic nose. At later stage of the study, a serum sample for coeliac tests will be collected. Patient outcome will be obtained during the hospital stay, at one-month after discharge and at one year.

Eligibility Criteria:
Inclusion Criteria:

All adult patients with abdominal pain.

Exclusion Criteria:

Under the age of 18 years
FOS Immunohistochemical Staining of Colorectal Cancer and Its Adjacent Tissues

Colorectal cancer tissue sections were obtained according to the inclusion criteria. The formalin was used to immersed all cancer specimens. And tissues were cut to 5 μm thickness and placed on glass slides before staining. Endogenous peroxidase activity was inhibited and blocked by de-paraffinizing, rehydrating, and using 5% bovine serum albumin at 37ºC for 30 min. The treated sections were incubated with anti-FOS (promab 30360) at 4ºC overnight and washed three times with PBS. After that, it is required that incubation with secondary anti-peroxidation sunflower at 37ºC for 30 minutes. After washing three times again with PBS, the sections were developed in diaminobenzidine and microscopic images were made by light microscopy.


Eligibility Criteria:
Inclusion Criteria:

* (a) patients with histologically confirmed CRC (b) patients who underwent resection of the primary tumor (c) patients at first visit who had not received treatment before blood testing.

Exclusion Criteria:

* (a) familial adenomatous polyposis or hereditary colon cancer (b) no signs of clinical infection, such as fever, on the day of blood collection; And (c) patients with multiple primary tumors during hospitalization.
Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease

Interstitial lung disease (ILD) often affects distal lung, and the evaluation of drug distribution to the relevant lung compartments is essential for development of new treatment options. This single center study will utilize samples obtained by transbronchial cryobiopsy (TBCB) procedure to assess the distribution of inhaled drugs in the lungs of the subjects with fibrotic lung disease using mass spectrometry techniques. The study will have a single visit and will include approximately 20 adult subjects with suspected fibrotic ILD and requiring TBCB as part of their diagnostic assessment. This will provide TBCB samples from up to 20 subjects, up to 5 of whom may also provide endobronchial forceps biopsy samples. The study will have 3 phases including screening to check the eligibility, biopsy phase in which all subjects will receive nebulized ipratropium bromide 500 microgram (mcg) for 10 minutes immediately before undergoing bronchoscopy and follow up phase from 7 to 14 days after the procedure. Drug distribution in the lung will be assessed by analyzing biopsy samples collected using mass spectrometry and imaging techniques.


Eligibility Criteria:
Inclusion Criteria:

* 18 and above years of age inclusive, at the time of signing the informed consent.
* Subjects with suspected ILD listed for TBCB for clinical reasons following review by the ILD services at University College London Hospitals (UCLH) in whom diagnosis has remained unclear following radiological and clinical assessment.
* A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied, may be included only if the investigator in consultation with the Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Male or Female.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions.

Exclusion Criteria:

* Subjects who have a known drug allergy or other contra-indication to ipratropium bromide.
* Known hypersensitivity to atropine or ipratropium bromide or any other known drug allergies that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
* As a result of the medical history, physical examination or screening investigations, the physician responsible considers the subject unfit for the study.
* The subject is unable or unwilling to perform study assessments and procedures correctly.
* Subjects with a recognized co-existing respiratory disorder (other than ILD) that in the opinion of the investigator would confound the study outcomes.
Inosine Energy Expenditure Study

Investigators want to test whether the intake of the nucleoside inosine increases the human energy expenditure. Inosine occurs as a metabolic intermediate in the human body and is sometimes taken as a dietary supplement by athletes.

For this purpose, investigators will measure the basal metabolic rate by indirect calorimetry. Study participants will then take inosine dissolved in water or placebo and energy expenditure will be assessed again.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* BMI between 18-27 kg/m2
* Age between 18 and 40 years

Exclusion Criteria:

* Chronic concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Thyroid disorders
Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer

A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.

Single-center, open-label, prospective, single-arm, phase I-II study

About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)

Eligibility Criteria:
Inclusion Criteria:

1. Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology
2. Peritoneal seeding proven by histology or cytology
3. Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel or cisplatin as adjuvant chemotherapy should be excluded)
4. Age 18 to 70 years old
5. Eastern Cooperative Oncology Group performance status \<_ 2
6. Estimated life expectancy of more than 3 months
7. Adequate bone marrow function (WBCs\>3,000/µL and absolute neutrophil count (ANC) \>1,500/µL and platelets\>100,000/µL),
8. Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance _\> 60ml/min
9. Adequate hepatic function: bilirubin \< 1.5 x UNL, AST/ALT levels \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL (except in case of bone metastasis without any liver disease)
10. Written informed consent

Exclusion Criteria:

1. Contraindication to any drug contained in the chemotherapy regimen
2. Other tumor type than adenocarcinoma
3. Presence or history of CNS metastasis
4. Gastric outlet or bowel obstruction
5. Evidence of serious gastrointestinal bleeding
6. Peripheral neuropathy \> grade 2
7. History of significant neurologic or psychiatric disorders
8. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
9. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
10. Other serious illness or medical conditions
Tiemann Mounted Urodynamic Catheter Technique for Difficult Bladder Catheterization

A report of a technique for insertion a soft urodynamic catheter into the bladder, when urethral obstruction causes the catheter to bend and fold over itself at the resistance site.

The urodynamic catheter is mounted on a 12F Coudé tip Tiemann catheter, which then carries the tip of the urodynamic catheter beyond the obstruction site into the bladder.

The Tiemann catheter-mounted urodynamic catheter technique can serve as a suitable option to insert a urodynamic catheter into the bladder in all male patients in whom it fails due to kinking.

Eligibility Criteria:
Inclusion Criteria:

- MEN THAT UNDERWENT URODYNAMIC STUDY EVALUATION BETWEEN 6/2011 TO 9/2013

Exclusion Criteria:

NONE

-
Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19

Primary objectives Part 1:

- To evaluate the safety and tolerability of COR-101 compared to placebo

Secondary objectives Part 1:

* To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19
* To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101


Eligibility Criteria:
Key Inclusion Criteria:

* Hospitalized for COVID-19 illness for ≤72 hours
* Positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test
* Presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID19 prior to study treatment

Key Exclusion Criteria:

* Diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19
* In the opinion of the investigator, is not likely to survive for \>48 hours beyond Day 1
* New onset stroke or seizure disorder during hospitalization and prior to Day 1
* History of relevant CNS pathology or current relevant CNS pathology
Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers

The purpose of this study is to study the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of REGN1154 in normal healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
2. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
3. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
4. Able to read or to understand the consent process, and willing to sign the informed consent form (ICF)

Exclusion Criteria:

Exclusion criteria include, but are not limited to the following:

1. Any illness or condition that would adversely affect the subject's participation in this study
2. Any clinically significant abnormalities observed during the screening visit
3. Use of certain medications taken before the screening visit
4. Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit
5. Hospitalization within 60 days of the screening visit
6. Any condition that would place the subject at risk, interfere with participation in the study
7. History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
8. History of certain other conditions
9. Positive urine, drug or alcohol screen result at screening
10. Known sensitivity to any of the components of the investigational product formulation
11. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
12. Live/attenuated vaccinations within 12 weeks of screening or during the study
An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced or Metastatic Soft Tissue Sarcoma (Study E7389-J081-217)

The purpose of the study is to evaluate the efficacy and safety of eribulin mesylate in subjects with soft tissue sarcoma who received at least one standard chemotherapy (an anthracycline or an ifosfamide monotherapy or a combination therapy).


Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed soft tissue sarcoma of high or intermediate grade
* Documented evidence of advanced or metastatic soft tissue sarcoma, not amenable to surgery or radiotherapy
* Within 6 months from the radiographic evidence of disease progression by RECIST criteria in the last chemotherapy regimen for advanced or metastatic soft tissue sarcoma
* Presence of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Subjects who received at least one standard chemotherapy for advanced soft tissue sarcoma (an anthracycline or an ifosfamide monotherapy, or a combination therapy)
* Subjects aged ≥ 20 years at the time of informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Adequate organ function
* Voluntary agreement to provide written informed consent

Exclusion Criteria

* A history of malignancies or recurrence within 5 years after the remission
* Significant cardiovascular impairment
* Any serious concomitant illness or infection requiring treatment.
* Hypersensitivity to either halichondrin B or halichondrin B chemical derivatives or both.
* Subjects who have previously participated in a study with eribulin (whether treated with eribulin or not).
* Any medical or other condition which, in the opinion of the principal investigator, will preclude participation in a clinical trial.
* Subjects who have received any anti-cancer therapy, including surgery, radiotherapy, immunotherapy, cytotoxic, hormonal, biological (including humanized antibodies) and targeted agents within 21 days, or any investigational agent within 30 days, prior to the first dose of study drug.
* Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to ≤ Grade 1, according to Common Terminology Criteria for Adverse Events (CTCAE), except for peripheral neuropathy of Grade 2 and alopecia.
* Subjects with known cerebral metastases with clinical symptoms or requiring treatment.
* Pre-existing peripheral neuropathy \> CTCAE Grade 2.
* Female subjects must not be pregnant with a negative by the pregnancy test at Screening, or breastfeeding.
* Subjects participating in other clinical trials
The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases

The purpose of this study is to determine the effect of aspirin desensitization on symptoms and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD).


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnose of aspirin-exacerbated respiratory disease
* History of physician diagnosed asthma.
* History of physiacian diagnosed chronic rhinosinositis with nasal polyps.
* Positive reaction to aspirin challenge test.
* Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).

Exclusion Criteria:

* Being smoker
* pregnancy
* Current breastfeeding
* History of bleeding diathesis
* History of transient ischemic attack or stroke, or diabetes.
* History of abnormal hepatic function
* Uncontrolled hypertension or use of beta blocker medication.
* History of gastrointestinal ulcers or gastrointestinal bleeding.
Effects of Mulligan's Technique in Subjects With Shoulder Impingement Syndrome

Participants will be initially assessed for their suitability for inclusion in the study and will undergo a physical screening of the affected shoulder and cervical spine by an experienced physiotherapist. After, participants will be attended 72 hours after data recording of the baseline measures (range of motion with a goniometer, pressure pain threshold with a algometer, and peak force with a dynamometer) for four sessions per week with 24 hours of interval between sessions. At each experimental week session, each participant will receive one of the two treatment conditions (MWM or sham) and then will repeats the assessment. In the following week, there will be a crossover condition of each individual and 24 hours after the last treatment session, the examiner will do the last assessment.


Eligibility Criteria:
Inclusion Criteria:

* history of shoulder pain of \>1-week duration, localized at the proximal anterolateral shoulder region consistent to Shoulder Impingement Syndrome (SIS);
* at least 1 positive impingement test (Jobe's test, Neer's test, Hawkins-Kennedy's Test) associated with painful range of motion during arm elevation; or pain during external rotation with the arm in 90 degrees of elevation in the coronal plane.

Exclusion Criteria:

* fibromyalgia (based on self-report),pregnancy, a history of onset of symptoms because of traumatic injury, other histories of shoulder injury, torn tendons, ligamentous laxity based on positive Sulcus test and apprehension test, numbness or tingling in the upper extremity, previous shoulder or neck surgery, systemic illnesses, body mass index \> 28kg/m2, corticosteroid injection 3 months before evaluation, physical therapy 3 months before evaluation.
Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy

The aim of this study was to evaluate the efficacy and safety of intratumoral injection of toluenesulfonamide(PTS) in combination with or without first-line chemoimmunization based on standard treatment for stage IV driver gene-negative non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Fully understand, be informed about the study and sign the Informed Consent Form (ICF); be willing to follow and be capable of completing all trial procedures；
2. Age ≥18 years and ≤75 years at the time of signing the ICF；
3. Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；
4. At least one measurable target lesion assessed by the investigator according to the requirements of RECIST 1.1 within 4 weeks prior to enrollment, except for lesions proposed for percutaneous PTS local injection；
5. Localized injectable lesions located in a more confined area of the outer lung bands, less than or equal to 5 cm in diameter; these may be primary lesions that are not amenable to surgical resection or localized recurrent lesions after surgical resection and radiotherapy treatment；
6. ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTS intratumoral injections；
7. Patients with localized lesions present and persistently stable (SD evaluated after two courses of treatment) after standard treatment with first-line chemoimmunotherapy；
8. Life expectancy ≥ 3 months；
9. Normal liver, kidney and heart function, normal blood routine, blood biochemistry, coagulation function and electrolytes and other physiological indicators.

Exclusion Criteria:

1. Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection;
2. Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc;
3. Have severe bleeding, clotting disorders, infections, dehydration, etc;
4. Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc;
5. History of severe emphysema and pulmonary alveoli;
6. History of drug allergy or contraindication to toluene sulfonamide;
7. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
8. The investigators determined that the patients had other conditions that made them unsuitable for enrollment.
Study of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors

This study is designed to determine if treatment with HRS-1167 alone is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18；
2. ECOG performance status 0-1;
3. Life expectancy is not less than 12 weeks;
4. Dose escalation and PK expansion part: Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists；
5. Efficacy expansion part：Ovarian Cancer、Breast Cancer、Pancreatic Cancer、Prostate Cancer or other cancer types with HRR gene mutation；
6. At least one target lesion (except maintenance therapy);
7. Adequate organ and marrow function as defined by the protocol.

Exclusion Criteria:

1. Surgery or chemotherapy within 4 weeks of the first dose of study treatment；
2. Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption；
3. Active HBV/HCV/HIV infection;
4. Untreated and/or uncontrolled brain metastases.