cyrilzakka/clinical-trials huggingface dataset:
Study of Asoprisnil in the Treatment of Uterine Fibroids.

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab values and vital signs.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment
* Otherwise in good health
* Premenopausal based on Estrogen and FSH levels
* Adequate endometrial biopsy with no significant histological disorder
* Agrees to use double-barrier method of contraception

Exclusion Criteria:

* Any abnormal lab or procedure result(s) the study-doctor considers important
* History of a blood-clotting disorder
* History of osteoporosis requiring treatment
* Any invasive procedure(s) (D\&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study
* Hemoglobin \< 8.0 g/dL
* Endometrial thickness ≥ 19 mm
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.


Eligibility Criteria:
Inclusion Criteria:

* Must have completed the 12-week study D3820C00004 through Visit 8.
* Provision of written informed consent prior to any study-specific procedures.
* Men and women who were between the ages of \>18 and \<85 years at the time of the screening visit for study D3820C00004.
* Continuing to receive a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies.
* Willingness to continue abstinence from all laxatives and other bowel regimens including prune juice and herbal products throughout this additional 12-week treatment period, and to use only bisacodyl as rescue medication if a bowel movement (BM) has not occurred within at least 72 hours of the last recorded BM.

Exclusion Criteria:

* Patients receiving opioid regimen for treatment of pain related to cancer.
* History of cancer within 5 years from the screening visit of study D3820C00004 with the exception of basal cell cancer and squamous cell skin cancer.
* Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
* Other issues related to the gastrointestinal tract that could impose risk to the patient.
* Pregnancy or lactation.
The Effectiveness of Tibial Nerve Mobilization in Patients With Tarsal Tunnel Syndrome

This randomized, clinical, single-blinded, controlledstudywasinitiallyplannedtoinclude 35 patients diagnosed with tarsal tunnel who applied to Kütahya Health Sciences University, Evliya Çelebi Training and Research Hospital, Physical Medicine and Rehabilitation outpatient clinic.Patients aged 20-55 years who were diagnosed with tarsal tunnel syndrome by electromyography (EMG) in the last 6 months were included in the study. The patients were randomized into two groups using the computer-assisted randomization method. Tibial nerve mobilization and foot-ankle range of motion exercises will be given to the study group, and only foot-ankle joint range of motion exercises will be given to the control group. All the patients were evaluated with the Visual Analog Scale (VAS), Foot Functional Index (FFI), Neuropathic Pain QuestionnaireN (NPQ) and Tibial Nerve ultrasonography before the intervention and at the fourth week of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-55 years who were diagnosed with tarsal tunnel syndrome by electromyography (EMG) in the last 6 months were included in the study.

Exclusion Criteria:

* Have a systemic inflammatory disease
* Presence of a cognitive disorder, receiving psychotherapy or any psychiatric treatment, disease affecting the central nervous system
* Being illiterate
* Having hearing, vision problems
* History of foot and ankle surgery
* Any pathology that may cause pain in the foot joint diagnosed on physical examination
* Inadequate function of any extremity that would prevent exercise
* The presence of a balance disorder or a disease that can disrupt the balance
* Diagnosis of advanced cardiac or lung disease for which exercise would be contraindicated
Time-dependent Amiodarone Treatment in Atrial Fibrillation

Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized into two groups. The first received intravenous amiodarone infusions continuously for 24 hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours.

The efficacy and safety of administering intravenous infusions of amiodarone for up to 72 hours were investigated and compared to the efficacy and safety of administering a standard 24 hours infusion of amiodarone. Specifically, the use of up to 72 hours infusions was considered as a new strategy to improve rates of conversion to sinus rhythm without altering the safety profile of the drug.

An open randomized clinical trial was conducted that included 60 emergency adult patients who were candidates for drug cardioversion after first symptomatic episodes of AF.

The patients were randomized in equal proportions and sequentially placed in one of two treatment groups; no patient knew to which group he or she belonged. The first group received intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 hours was reached. The second group received intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 hours for up to 72 hours.

All patients were continuously monitored using electrocardiograms, and echocardiograms were performed within 24 hours after the randomized trial began. The exact time of each patient's cardioversion was documented. In addition, general laboratory tests, lipid profiles, thyroid profiles and chest X-rays were obtained for all patients.

A sample size of 30 subjects in each group was calculated. A conversion rate of 60% was assumed, according to literature, and an estimated increase to 90% was assumed for the experimental group to find differences with a power of 0.8 and an alpha error of 0.05.

The primary goal was to obtain was a sinus rhythm conversion rate. The secondary goal was to obtain a combined complication rate by noting various complications in the patients, such as phlebitis, symptomatic hypotension that required vasopressors, bradycardia, nausea, vomiting and any organ embolism.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Emergency patients
* First symptomatic episodes of Atrial Fibrillation

Exclusion Criteria:

* Hemodynamic instability,
* Previous use of antiarrhythmic drugs
* Use of digoxin seven or fewer days prior to the study
* Active thyroid disease
* Known adverse reactions to amiodarone
* Other ventricular arrhythmias
* Contraindications for anticoagulation
* Acute renal failure
* Chronic liver disease
* Transaminase levels that were twice the normal levels
* Acute pulmonary edema
* Uncontrolled hypertension (\> 180/110 mmHg)
* Unstable angina
* Patients who were pregnant and/or breast feeding
Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR Mutation

Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR mutation to collect and analyze the patient's clinical features, diagnosis, and treatment results.

The Korean EGFR Registry is a prospective multicenter observational cohort study designed to enroll all stage EGFR-mutated non-small cell lung cancer (NSCLC) patients. However, due to the extended follow-up period required to confirm clinical outcomes, a retrospective cohort has been included. This retrospective cohort comprises patients with recurrent or metastatic NSCLC who began taking EGFR TKI after January 2021. The recruitment phase was planned to span 36 months, commencing in May 2022, with scheduled follow-up activities continuing until December 2026. The target enrollment for this study is set at 2,000 patients, with competitive enrollment to be carried out across 40 university hospitals in Korea.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 20-year-old with Korean nationality
2. A person who voluntarily signed the informed consent form for this study
3. All stage Non small cell lung cancer patients with EGFR mutation or Metastatic or recurred EGFR mutated NSCLC patients started with EGFR TKI treatment from 2021-01-01.

Exclusion Criteria:

1. A person who is not confirmed NSCLC histologically or cytologically.
2. A person who doesn't consent to the study.
3. A person who is unable to complete the study judged by the investigator.
The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis

7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.

7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days All patients are followed with regular follow up after 2,4,8,12,16, 20 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Ulcerative Colitis (UC)
* SCCAI between 4 and 10 at inclusion
* On a stable dose of 5-aminosalicylic acid (5-ASA) or without current treatment.
* Previous treatment with glucocorticoids, thiopurines and/or biological treatment was accepted.
* Fecal Calprotectin \> 250 mg/kg
* Colonoscopy performed within the last 3 years
* Capable of writing and speaking Danish
* Attending regular follow-ups by a specialist in gastroenterology.

Exclusion Criteria:

* Biological treatment within the last four weeks
* Treatment with antibiotics within 48 hours before intervention
* Alcohol use above current Danish guidelines (14 units/week for men and 7 units/week for women)
* Pregnancy or planned pregnancy
* Active cancer disease
* Medical treatment of mental disorder
* Other chronic gastroenterological disorder besides UC, Irritable Bowel Syndrome (IBS) or Reflux-disease.
Evaluation of Intuitive Eating and Hedonic Hunger in University Students

This study was conducted with the participation of 62 female and 38 male students between the ages of 18-36 studying at various universities. A questionnaire consisting of seven parts was applied to the participants. In the first part, 20; demographic data and general health status of the participants; There were 11 questions including nutritional habits and anthropometric measurements (body weight and height). The other parts of the questionnaire were the Intuitive Eating Scale (IES-2), Power of Food Scale (PFS-Tr), Food Craving Questionnaire (FCQ-T), the Pittsburg Sleep Quality Scale (PUKI), Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) and Palatable Eating Motive Scale (PEMS), respectively contains. Consent from the participants was also obtained with the questionnaire form.


Eligibility Criteria:
Inclusion Criteria:

* University students who agreed to participate in the study

Exclusion Criteria:

* University students who did not want to participate in the study baby and kids elderly adolescents pregnant women breastfeeding mothers
Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material

This clinical study aims to assess the efficacy of using calcium silicate based sealer as a capping material after complete removal of coronal pulp tissue. The study will evaluate both the clinical and radiographic changes.

Root canal treatment has always been considered the first line of treatment for carious teeth with symptomatic irreversible pulpitis for a long time. However, after the evolution of calcium silicate based materials a more conservative option, which is pulpotomy began to gain reliability, especially that it preserves the vitality of the radicular pulp, clinically simpler, less time-consuming, and more cost-effective compared to conventional root canal treatment.

In this study the investigators assess the clinical and radiographic success rate of using calcium silicate based sealer as a pulp capping material in permanent molars after pulpotomy.

For the best of the investigators\&#39; knowledge, there is no available clinical data on the use of calcium-silicate based sealers as a pulp capping material in pulpotomy of permanent molars with symptoms of irreversible pulpitis.

Eligibility Criteria:
Inclusion Criteria:

* Vital mandibular molar teeth with mature apices.
* Teeth that respond positively to cold testing.
* Teeth without any signs of necrosis including sinus tract or swelling.
* Teeth with caries extending ≥ 2/3 of dentine or exposing the pulp.
* Teeth with symptomatic irreversible pulpitis with/without apical periodontitis.
* Teeth without periodontal diseases or mobility.
* Teeth without root resorption, detectable pulp chamber and root canal calcification or history of trauma.
* Patients from both genders with age range from 20 to 45 years old.
* Patients with good or moderate oral hygiene and without any systemic diseases.

Exclusion Criteria:

Pre-operative criteria:

* Non-vital teeth.
* Teeth with irreversible pulpitis with apical periodontitis.
* Teeth with immature apices.
* Teeth with Periodontal disease or mobility grade II or III.
* Teeth that are badly decayed and need post and core placement.
* Patients refused to continue treatment procedures or refuse to commit to periodic follow-up sessions.
* Non-restorable teeth.

Intra-operative criteria:

* If hemostasis could not be achieved within 6 minutes after full pulpotomy.
* Teeth with partial necrosis.
* No bleeding after access cavity preparation.

Post-operative criteria:

* presence of Swelling.
* presence of Sinus tract.
* Pain on percussion after the end of the first week.
* Pain with palpation.
* Pain on biting after the end of first week.
* Mobility of the tooth.
* Fracture of tooth structure that renders the tooth non-restorable.
* Fracture of the restoration during the evaluation.
* Probing depth more than 3 mm.
Median Effective Dose of Remimazolam for Sedation in Elderly Patients

Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has different advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. In addition, remimazolam has a very short onset time, and even after the continuous infusion, the onset of remimazolam is fast, and even after continuous injection, the effect disappeared very quickly due to the short context-sensitive half time. And through continuous infusion, the patient's depth of anesthesia can be maintained constant. In addition, the short duration of action and the ability to quickly reverse the effect of flumazenil suggest that remimazolam can be used effectively under general anesthesia as well as under general anesthesia. Remimazolam can be used as a continuous infusion for general anesthesia. However, it has also been reported to be used for sedation by continuous infusion or divided intravenous infusion. However, the effective maintenance dose of remimazolam for sedation without mechanical ventilation has not been established. In addition, age might be an important factor for determining the appropriate dose of remimazolam.

In this study, we aim to identify the median effective dose of remimazolam for maintaining sedation in elderly patients undergoing lower limb surgery under spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* age: equal or older than 20 years
* ASA PS: 1-3
* patients who are scheduled to undergo lower limb surgery under spinal anesthesia with sedation using remimazolam

Exclusion Criteria:

* Patients who refuse to participate in this study
* Patients with hypersensitivity to benzodiazepine or flumazenil
* Patients with severe renal/hepatic disease
* Patients with drug/alcohol abuse
* Patients who take antidepressants, anticonvulsants, psychoactive drugs chronically
* Patients with difficulty in communication
* Patients with severe obstructive sleep apnea or other airway problems
* Patients contraindicated to regional anesthesia
* Patients judged to be inappropriate for this study
A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma

This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma to compare the progression free survival (PFS) and overall survival (OS)


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures.
2. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
3. Has received and progressed on at least 2 lines of systemic therapy (anti-PD-(L)1 in combination with platinum or fluoropyrimidines, paclitaxel/docetaxel, irinotecan). A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy. The subject has ≤ 4 prior lines of systemic therapy.
4. Has histopathologically confirmed CLDN18.2-positive disease.
5. Is a man or woman of 18 years of age or older at the time of signing the ICF.
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Exclusion Criteria:

1. Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease.
2. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
3. Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).
4. Has received the last dose of an anti-cancer therapy (including traditional Chinese medicine indicated for gastric cancer in the package insert, but excluding herbal prescriptions) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment.
5. Plans to receive other anti-cancer therapy during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed).
Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer

The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Have histologically or cytologically proven adenocarcinoma of the pancreas.
3. Have metastatic disease.
4. Have disease progression.
5. Patients with the presence of at least one measurable lesion.
6. Patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
7. ECOG performance status 0 or 1
8. Life expectancy of greater than 3 months.
9. Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
10. Must use acceptable form of birth control while on study.
11. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Known history or evidence of brain metastases.
2. Had surgery within the last 28 days
3. Had chemotherapy, radiation, or biological cancer therapy within the last 14 days
4. Have received a prophylactic vaccine within 14 days or received a live vaccine within 30 days of planned start of study therapy.
5. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
6. Systemic steroids within the last 14 days
7. Use more than 2 g/day of acetaminophen.
8. Patients on immunosuppressive agents.
9. Patients receiving growth factors within the last 14 days
10. Known allergy to both penicillin and sulfa.
11. Severe hypersensitivity reaction to any monoclonal antibody.
12. Have artificial joints or implants that cannot be easily removed
13. Have any evidence of clinical or radiographic ascites.
14. Have significant and/or malignant pleural effusion
15. Have had a new pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study treatment
16. Infection with HIV or hepatitis B or C at screening
17. Significant heart disease
18. Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
19. Are pregnant or breastfeeding.
20. Have rapidly progressing disease
The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations

The intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention (PCI) of Medina 0,0,1 coronary bifurcation lesions. Patients will be randomized to treatment with Plain Old Balloon Angioplasty (POBA)or treatment with DEB.


Eligibility Criteria:
Inclusion Criteria (main):

* De-novo Medina type 0,0,1 bifurcational native coronary artery lesion (reference diameter:\>2.0 mm \<3.5 mm, length of stenosis: ≤ 10 mm), the diameter of the side branch shall be smaller or equal to the diameter of the distal end vessel

Exclusion Criteria (main):

* Reference side branch diameter \> 3.5 mm
* Evidence of extensive thrombosis within target vessel
* Patients with another coronary stent implanted previously into the target branch or bifurcation ≤ 15 mm distant to the current lesion, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD- BIF