cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects

To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women between 18 and 50 for the entire study, except women enrolled from India should be aged between 18 and 40 years, requesting contraception
* Smokers may not exceed 35 years of age

Exclusion Criteria:

* Pregnancy or lactation (delivery, abortion, or lactation within less than three cycles before the start of treatment)
* Body mass index (BMI) \> 32 kg/m2
* Any disease or condition that may worsen under hormonal treatment
* Undiagnosed abnormal genital bleeding
* Other contraceptive methods such as sterilization, hormonal contraception, IUD within 30 days of Visit 1, monthly contraceptive injection within a period of three times of the injection interval before start of treatment
* Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors

This intermediate-size IND will treat participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation and appropriate HLA class II match (HLA-DRB1\*07:01).

This study will treat two identified patients with metastatic pancreatic adenocarcinoma and metastatic pancreatic cancer who have both been treated with standard of care therapies and found to have disease progression. Both of these patients have KRAS G12V mutations in their cancers and express the HLA-DRB1\*07:01 HLA class II molecule. As such, they are candidates for adoptive cell therapy with autologous gene-engineered T cells expressing HLA-DRB1\*07:01-restricted KRAS G12V reactive T-cell receptors (TCR).

Adoptive T-cell therapy is a type of immunotherapy which involves isolation of T cells from a patient, followed by an amplification of those T cells in the lab to large numbers, and reinfusion of the T cells back to the patient.

In addition to the two identified patients, the protocol will remain open for additional participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (DRB1\*07:01).

Eligibility Criteria:
Patients with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (HLA-DRB1\*07:01)
Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function

Evaluation of the pharmacokinetics (PK) of TBPM-PI-HBr in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult males or females, 18 years of age or older.
* BMI ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg
* Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with Renal Disease).
* Non-smoker for at least 1 month prior to screening for the study.
* Ability and willingness to abstain from alcohol, caffeine, xanthinecontaining beverages or food.

Key Exclusion Criteria:

* Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* Electrocardiogram (ECG) with QTcF interval duration equal or greater than 500 msec
* Hemoglobin (HB), hematocrit (HCT), white blood cell count (WBC), or platelet count less than the lower limit of normal range of the reference laboratory (Cohort 1). HB \< 8.5 gm/dL, WBC ≤ 3,000 cells/μL or platelet count ≤ 100,000 cells/μL (Cohorts 2-5).
* Results of biochemistry tests for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin greater than 1.5 X the upper limit of normal (ULN) for the reference laboratory.
* Recent history of known or suspected Clostridium difficile infection.
* History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic academia).
* History of chronic liver disease, cirrhosis, or biliary disease.
* History of seizure disorder except childhood history of febrile seizures.
* Positive urine drug/alcohol testing.
* Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibodies.
* History of substance abuse or alcohol abuse.
* Use of antacids within 24 hours prior to study drug administration.
* Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication.
Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape

The investigator's purpose was to compare the effects of the surgical drain and kinesiologic tape applications on postoperative morbidity after mandibular third molar surgery.

A total of 90 patients will be scheduled for impacted third molar surgery. The patients will be divided into 3 groups.All surgeries will be carried out by the same surgeon. Group A will be treated with kinesiologic tape, Group B will be treated with a surgical drainage tube and Group C will be control group. After surgery in control group, routine surgical extraction will be performed.The investigators will compare postoperative pain, swelling, trismus and patients' comfort.

The duration of each procedure from the start of the incision to the time of last suture placement will be noted.

Patients are recalled on days 2, 7, 14 postoperative pain, facial swelling, maximum mouth opening, wound dehiscence. For the assesment of the pain, visual analog scale will be used. For the swelling evaluation, measurement will be done from the different three region on the face:

* Tragus-Pogonion
* Tragus-Labial Commissura
* Angulus Mandible-Lateral canthus

Maximum mouth opening will be noted before and after (one week later) the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 of age,
* Asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B)
* Fully covered with mucosa and bone

Exclusion Criteria:

* Alcohol abuse,
* Smoking,
* Pregnancy,
* No allergy
* Presence of acute severe periodontitis.
Evidence-Based Robot-Assistant in Neurorehabilitation

The purpose of this study is to investigate the efficacy, acceptability, and safety of the therapeutic system E-BRAiN for the treatment of stroke-related impairments.

This randomized controlled trial, RCT with cross-over design sequentially allocates participants with stroke-related impairment to both a two week course of conventional rehabilitation therapy and a two week course of therapy using the therapy system E-BRAiN (purpose-built therapy system using a socially interactive humanoid robot); participants are randomly allocated to the sequences "conventional =\> robot" or "robot =\> conventional". Stroke survivors with one of the target syndromes, i.e. mild arm paresis, or moderate to severe arm paresis, or visuospatial neglect are invited to participate.

Eligibility Criteria:
Inclusion Criteria:

* Age at study entry ≥ 18 years
* Stroke (ischemic stroke, non-traumatic intracerebral haemorrhage, subarachnoidal haemorrhage)
* Incomplete arm paresis (Motricity Index, arm score \>1 \[Min\] and \< 100 \[Max\]) or
* Visuospatial neglect (clinical signs and NET subtest "star cancellation" score \< 50)
* Candidate able to consent and provides informed consent or
* legal representative provides informed consent

Exclusion Criteria:

* Pregnant or breast feeding
* Obliged to live in an institution by law or public authority
* With case presentation arm paresis: another condition that causes arm paresis is present
* With case presentation visuospatial neglect: another condition that causes a relevant visual-perceptual deficit that cannot be compensated is present; exception: homonymous visual field deficits are not an exclusion criterion
GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery

Transradial approach has become the default arterial access for coronary angiography (CAG) and percutaneous coronary intervention (PCI), mainly due to lower incidence of bleeding compared to transfemoral access.1 However, TRA is not deprived of local access site complications such as radial artery occlusion (RAO), occurring in approximately 5.2% of patients, compartment syndrome, pseudoaneurysm, hematoma, and arteriovenous fistula. Recently, a novel approach has been proposed, the access through the distal radial artery (distal transradial access, dTRA), located in the anatomical snuffbox. Initial studies regarding the dRA have shown feasibility and benefits, including shorter hemostasis time, fewer local access site complications and potentially lower incidence of RAO.

GlideSheath Slender is a novel sheath which has a hydrophilic coating and is made of a thinner material than traditional sheaths. As a result, the external diameter of the 5 Fr GlideSheath Slender sheath is 1 Fr lower compared with conventional arterial sheaths.

The purpose of the present study was to investigate whether the use of the Slender sheath affects the time of hemostasis, sheath insertion time, crossover rate to conventional radial access, pain associated with the procedure and incidence of local access site complications (RAO, distal radial artery occlusion, fistula, hematoma) in patients undergoing diagnostic angiography through the distal radial artery.

Patients fulfilling the enrollment criteria will be randomized 1:1 to GlideSheath Slender versus conventional 5Fr arterial sheath for access through the distal radial artery (dTRA). In case an interventional procedure is required then the initial sheath will be exchanged to a larger sheath according to the circumstances of the case and the patient will not be included in the analysis.

For randomized patients sheath insertion time, necessity for crossover to conventional radial access, pain associated with the procedure (visual pain scale) and occurrence of hematoma will be recorded. Follow-up ultrasound 7-10 days after the procedure for detection of RAO, distal radial artery occlusion and fistula formation will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Indication for coronary angiography
* Age\>18 years
* Informed consent

Exclusion Criteria:

* Non-palpable right radial artery
* Prior CABG
* STEMI
* Prior right transaradial intervention within the previous 2 months
* Hemodynamic instability
* Anatomical restrictions (fistula orthopaedic problems, etc)
Effect of Mindfulness- Based Stress Reduction Program in the Elderly onSpiritual Well- Being and Meaning of Life

This quasi-experimental study with a pretest-posttest control group will be conducted to determine the effect of a mindfulness-based stress reduction program on spiritual well-being and the meaning of life among the elderly.

Aging is a natural part of the life process, during which individuals undergo numerous biological, psychological, and social changes. In this period, people often engage in reflecting on past life experiences, seeking meaning in life, and searching for a spiritual direction. At the same time, physical limitations brought about by aging, social isolation, and losses can increase stress levels in older individuals. Stress can have adverse effects on their health, including anxiety, depression, sleep problems, and overall health deterioration.

Mindfulness-Based Stress Reduction (MBSR) helps individuals develop skills to accept the present moment, cope with stress, and regulate emotions. Spiritual well-being plays a significant role in enhancing the quality of life for older adults. The MBSR program enables older individuals to consciously focus their attention on the present moment, allowing them to live more mindfully in the "here and now" instead of dwelling on past anxieties or future worries.

This study examines the effects of the MBSR program on spiritual well-being and meaning-making in older adults, highlighting the importance of spiritual support and mindfulness practices in later life. The research aims to contribute to spiritual support programs for older individuals. A hypothesis will be tested to determine whether there is a difference between the intervention and control groups after the program's implementation.

Eligibility Criteria:
Inclusion Criteria:

* Being 65 years or older,

  * Living in the nursing home where the research will be conducted,
  * Being competent to continue the health education program,
  * Getting at least 23 points from SMMT
  * No hearing-visual impairment,
  * Being literate,
  * Volunteering to participate in research.

Exclusion Criteria:

* Having a communication barrier,
* Being diagnosed with dementia,
* Not having attended any session of the eight-session training program,
* Getting a score lower than 23 points from SMMT,
* Having psychosis or mental disability that may cause cognitive impairment,
* Do not have a terminal illness.
* Not having participated in any of the Pretest, Posttest-1 and Posttest-2.
Epidemiology and Management of Malnutrition of Patients Hospitalized at the Pitié-Salpêtrière Hospital: a One-day Survey Combined With Focus Groups (Mixed Methods)

According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay.

Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS ( High Authority for Health) criteria for 2019 (if age \<70 years) and 2021 (if age ≥ 70 years).

According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay.

Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS (High Authority for Health) criteria for 2019 (if age \<70 years) and 2021 (if age ≥ 70 years).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Hospitalized for at least 2 days in a Pitié Salpêtrière department of the 8 selected DMUs.
* Patient informed and not objecting to participation in the study.

Exclusion Criteria:

* Be hospitalized in a PRM, SMR, radiotherapy or adult psychiatry department
* Be hospitalized in an intensive care or resuscitation unit of the 8 selected DMU
* Be at the end of life, as determined by the referring clinician
* Have a communication barrier preventing the collection of declarative data
* Pregnancy in progress; 6. Patient under guardianship.
A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach

The purpose of this study is to compare several analgesics given in approved daily doses in combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding properties and their effects on the stomach in healthy volunteers.

The purpose of this randomized, multiple-dose, single-blind, parallel-group study is to examine in healthy volunteers the effects of analgesics given in approved daily doses in addition to daily cardio-protective doses of aspirin (81 mg) on the stomach. All subjects are examined endoscopically before receiving study medication, and at the end of treatment on Day 9. Each subject takes 81 mg of aspirin daily plus one of the following treatments to be taken daily on Days 1 through 8: four doses of acetaminophen 1000 mg, three doses of ibuprofen 400 mg, two doses of naproxen sodium (440 mg in the morning and 220 mg in the evening), four doses of aspirin 650 mg, two doses of celecoxib 200 mg, one dose of rofecoxib 25 mg, or no additional study medication. On Day 9, one dose of aspirin 81 mg and only one dose of the assigned treatment drug are taken prior to having an endoscopy. The primary endpoints of the study are the effects of the analgesics on the inhibition of COX-1 activity by aspirin, and any injury to the stomach mucosa, as determined by direct endoscopic observation. Safety assessments consist of routine monitoring for adverse events, as well as endoscopic examination of gastric mucosa for erosions and ulcerations occurring during the treatment phase. The study hypothesis is that the effects of acetaminophen on the stomach do not differ from the effects of ibuprofen, naproxen, aspirin, celecoxib, or rofecoxib. 81 mg aspirin and 1of 7 treatments for 8 days: acetaminophen 1000mg 4xday, ibuprofen 400mg 3xday, naproxen 440mg morning and 220mg evening, no additional study medication, aspirin 650mg 4xday, celecoxib 200mg 2xday,rofecoxib 25mg 1xday. On Day 9, 1 dose aspirin \& 1 dose study drug before endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* In general good health with normal hemostatic (blood coagulation) parameters
* able to swallow study medication
* non-smoker
* negative for H. pylori infection
* if female, must not be pregnant or breast feeding

Exclusion Criteria:

* Have taken anti-inflammatory drugs within one week of study entry, any analgesic within 24 hours before baseline endoscopy, or systemic steroids within 6 weeks of study entry
* unable to tolerate oral drugs or have had gastrointestinal disease or prior gastrointestinal surgery that could interfere with the study medication
* unable to understand or follow instructions
* have a medical condition or clinically significant abnormal laboratory results that may be relevant to participation in the study
Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.

This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice.

PRIMARY OBJECTIVES:

I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues.

II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries.

III. Assess the impact of PTeye on minimizing risk of post-surgical complications.

Participants will be randomized to either the experimental or control arm.

The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the PTeye will indicate to the surgeon if the tissue is likely parathyroid or not.

For patients assigned to the control arm, the surgeon will not use the PTeye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Participants will be follow-ed up for up to 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* All adults \>=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery
* All adult (\>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Exclusion Criteria:

* Children and minors
* Pregnant women
* Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
* Patients with secondary or tertiary hyperparathyroidism
Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma

Primary Objective:

Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed.

Secondary Objectives:

1. Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma.
2. Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy.
3. Assess the quality of life of patients receiving RT-PEPC treatment


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles: CD5(+),CD23(-), CD19(+) or CD20(+), cyclin D1(+), and CD10(-)
* Patient has persistent / recurrent disease after standard chemotherapy
* Patient has not received either standard or investigational drugs within the last 3 weeks
* Available frozen tumor tissue obtained since completion of last prior therapy (rebiopsy if needed)
* Patient has measurable disease as defined by a tumor mass \> 1.5 cm in one dimension
* Age \> 18 years
* Absolute granulocyte count \> 1000 cells/mm3
* Platelet count \> 50,000 cells/mm3
* Creatinine \< 2.0 x ULN
* Total bilirubin \< 2.0 x ULN
* Patient has KPS \> 50%
* Patient agrees to use birth control if of reproductive potential

Exclusion Criteria:

* Known central nervous system (CNS) involvement by lymphoma
* Known HIV disease
* Known peripheral neuropathy \> grade 2
* Patient is pregnant or nursing
* Patient has had major surgery within the last 3 weeks
* Patient is receiving other investigational drugs