cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-79032421 and to determine the safety and tolerability of JNJ-79032421 at the RP2D(s).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of one of the following unresectable/locally advanced or metastatic solid tumors: a) Ovarian cancer includes high grade serous epithelial ovary, fallopian tube, or primary peritoneal cancer. Participants must have progressed after at least 2 prior lines of systemic therapy and have either, i) platinum-refractory disease (ie, persistent disease following completion of platinum-based primary chemotherapy); or ii) platinum-resistant recurrent disease; b) Primary pleural or peritoneal mesothelioma. Sarcomatoid and well differentiated papillary histologies are not allowed. Participants must have progressed after at least 1 prior line of systemic therapy; c) Pancreatic ductal adenocarcinoma. Other histologies and mixed histologies are not allowed. Participants must have progressed after at least 1 prior line of systemic therapy.
* Measurable or evaluable disease: a) Part 1: Measurable or evaluable disease; b) Part 2: At least one measurable lesion per RECIST v1.1. Participants with mesothelioma must have disease measurable per mRECIST v1.1.
* Can have a prior or concurrent second malignancy (other than the disease under study) whose natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1.
* Selected participants in the pharmacokinetic and pharmacodynamic (PK/PD) cohorts (Part 1) as well as selected participants in Part 2 must agree to undergo mandatory tumor biopsies.

Exclusion Criteria:

* History of known central nervous system (CNS) or leptomeningeal involvement.
* Left ventricular ejection fraction on screening echocardiogram below normal institutional limits.
* History of talc pleurodesis for pleural effusion within 3 months of starting study treatment.
* Concurrent empyema of the lung pleural space requiring antibiotics or chest tube or evidence of resultant fistula formation.
* History of hyperthermic intraperitoneal chemotherapy (HIPEC) within 6 months of starting study treatment.
Effects of Cold and Kinesio Taping in Individuals With Rotator Cuff Tendonitis

Rotator cuff tendonitis (RCT) is one of the most common shoulder pathologies, causing pain, limitation of shoulder joint movements, and impaired function. Patient education, medical treatment, corticosteroid injections, physiotherapy rehabilitation approaches are the most common treatment options applied to alleviate the symptoms of RCT. Despite these various treatment methods, there are currently no specific guidelines regarding the most appropriate and effective intervention for RCT treatment. This is mainly because adequate, high-quality studies are lacking in RCT management. To the best of our knowledge, no studies have evaluated the effects of Kinesio Taping (KT), which has become a popular approach in recent years, and Cold Therapy (CT), which has often been used as a therapeutic agent since immemorial, on individuals with RCT. In this regard, this study aimed to investigate and compare the short-term effects of KT and CT on pain and upper extremity functionality in individuals with RCT.


Eligibility Criteria:
Inclusion Criteria:

* RCT diagnosis
* Excluding other shoulder pathologies by magnetic resonance imaging (MRI) and specific tests

Exclusion Criteria:

* Glenohumeral joint dislocation/subluxation;
* Acromioclavicular sprain;
* Rotator cuff tear;
* Glenohumeral joint instability;
* Calcific tendinitis of the shoulder;
* Acromioclavicular joint pathologies,
* Hyperlaxity;
* Any fracture in the shoulder;
* Diabetes, thyroid and any vascular or rheumatologic disease;
* Glenohumeral joint deformities;
* Superior labrum anteroposterior (SLAP) lesion;
* Shoulder pain lasting more than six months;
* History of shoulder surgery;
* Intra-articular steroid injection
TEL and Clam Shell Exercises Affect After ACL

The purpose of this study to determine the effects of the addition of isolated hip strengthening exercises to traditional rehabilitation after Anterior cruciate ligament reconstruction (ACLR). Clamshells exercises unique in scene because it mainly focuses on the muscle surrounding the hip whereas the traditional exercises mostly paid attention on quads and hams exercise

In 2020, researcher conducted a randomized controlled clinical trial to determine "Does six-weeks of Hip-focused exercises has the effects on Time to Stabilization after Anterior Cruciate Ligament Reconstruction". The purpose of these study to determine the relationship between muscle strength and time taking to increase the performance of knee. The main findings suggesting that rehabilitation program targets on strengthen the hip muscles in comparison with traditional exercises of knee demonstrate an improvement of knee functions in individual with Anterior cruciate ligament reconstruction (ACLR).

In previous studies there is very less literature regarding determining effects of the clamshells exercises on extension lag after anterior cruciate ligament reconstruction. Therefore there is a dire need to explore the effect of the clamshells exercises on post anterior cruciate ligament reconstruction extension lag. This study aims in the management of pain disability and functional impairment in persons with extension lag with clamshells exercises after ACL reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-40
* Both Genders (male \& female)
* History of Anterior Cruciate Ligament Reconstruction (ACLR) between 1-3 years

Exclusion Criteria:

* Any other previously serious knee pain and/or surgery.
* Limiting of knee range of motion.
* Any traumatic conditions around the knee, or any infectious or tumors conditions
* Pregnancy, any recently underwent abdominal and back surgery.
The Effect of Moderate-Dose Steroid Therapy in Sepsis

Despite the new developments in sepsis treatment, mortality rate is still high. Discussions on steroid treatment in sepsis are going on. In this study, we aimed to investigate the effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis on prognosis in patients with sepsis.

This prospective, randomized, single-centre, double-blind, placebo-controlled trial was conducted between April 2005 and May 2008 in the department of Medical ICU and the Department of Infectious Diseases of Erciyes University Medical School. The study was approved by our Institutional Review Board and informed consent was obtained from the patients' relatives. The study did not alter therapy, and each patient's clinical care was determined by their own physician.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 17 years old and diagnosed with sepsis were included in the study consecutively

Exclusion Criteria:

* Already known pre-existing adrenal disease or adrenalectomy, known malignancies, tuberculosis that might have involved the adrenal gland, and administration of steroids within the 3 months before the admission. In addition, patients with burns, hemorrhagic shock or those who had suffered myocardial infarction were not included.
Comparison of CPAP Modalities for OSA Treatment

This is a crossover study comparing the effect of CPAP Fixed Pressure, CPAP FLEX -PLUS and Sensawake on sleep quality, adherence to treatments, and PSG parameters in patients with moderate to severe OSA.

Obstructive sleep apnea (OSA) is associated with behavioral, cognitive, metabolic and cardiovascular conditions. Continuous Positive Airway Pressure (CPAP) is the gold standard treatment for OSA. Despite being the most effective treatment for OSA, 46 to 83% of patients do not adhere to CPAP. New technologies for CPAP treatment have been developed in order to improve patient's comfort, adherence and effectiveness in reducing apnea, hypopneas and flow limitation events. As an example, the FLEX- PLUS technology which increases inspiratory positive pressure and decreases expiratory positive pressure would soften the rhythm of breathing. Sensawake is another technology which evaluates breathing pattern changes during CPAP therapy. When the breathing pattern suggests that patient is awake, a prompt relief in pressure is activated, like ramp feature. However, it is not clear whether CPAP FLEX- PLUS or Sensawake are superior compared with fixed pressure CPAP, in terms of polysomnographic parameters, especially flow limitation or adherence to treatment. Objective: To compare the effect of fixed pressure CPAP, CPAP FLEX- PLUS and Sensawake on sleep and compliance parameters in patients with moderate to severe OSA. Methods: Fifty male patients with moderate to severe OSA will be included in a crossover design study. All patients will use each CPAP modality for 30 days in a randomized order, namely CPAP with Fixed Pressure, Flex- PLUS and Sensawake. A week of washout period will be applied between treatments. All patients will wear the same nasal mask brand. At the end of each treatment (every 4 weeks), patients will undergo polysomnography and fill out Epworth, FOSQ, Pittsburgh questionnaires and a visual analogue scale assessing CPAP side effects and patient´s comfort. Finally, adherence to CPAP modalities will be systematically checked.

Eligibility Criteria:
Inclusion Criteria:

* male gender
* apnea-hypopnea index (AHI) score of ≥20 events/hour of sleep
* 30-65 years-old
* body mass index (BMI) ≤40 Kg/m²

Exclusion Criteria:

* major neurological, psychiatric, cardiac or respiratory disease
* use of psychoactive medication
* other sleep disorders
* patients referred to PSG for Bilevel, considered the need for PAP ≥ 18 cm H2O
* Previous contact with any OSA treatment.
Inspiratory Muscle Training for Breathless Patients With Chronic Obstructive Pulmonary Disease and Heart Failure

The purpose of this study is to determine whether inspiratory muscle training is effective to improve breathless and exercise intolerance in symptomatic patients with chronic obstructive pulmonary disease (COPD) plus chronic heart failure (HF).

Chronic obstructive pulmonary disease (COPD) and heart failure with reduced left ventricular ejection fraction (HF) are leading causes of disability and death worldwide. Unfortunately, COPD and HF coexist in up to a third of elderly patients making the so-called COPD-HF overlap (CHO) a major challenge to Health Care Systems. In addition, population ageing anticipates that CHO prevalence will further increase in the next decades.

Intolerance to exertion due to disabling breathlessness is the hallmark of COPD and HF and these abnormalities are notoriously potentiated by diseases coexistence.

The inspiratory muscles are centrally related to the pathophysiology of exertional dyspnea in COPD and HF. In both populations a higher central motor command output is required to maintain adequate force generation in the face of weaker inspiratory muscles. This information is interpreted as "shortness of breath".

There is well established evidence gained from recent meta-analyses indicating that inspiratory muscle training (IMT), as a standalone therapy, significantly improves inspiratory muscle function (strength and endurance), dyspnea during daily activities, and functional exercise capacity in COPD and HF. Previous findings indicate that reduced pressure-generating capacity reflecting inspiratory muscle weakness is frequently observed in patients with COPD-HF and related to a clinically-relevant outcome: exertional dyspnea. These findings set the scene for a randomized controlled trial to investigate the potential role of IMT in dyspnea palliation in CHO patients.

Objectives

To determine the effects of IMT on:

1. Dyspnea on daily life
2. Inspiratory muscle strength and endurance
3. Dyspnea on exertion and time to exercise intolerance

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnoses of COPD and HF under optimized clinical treatment as judged by the accompanying physician
* Reduced left ventricular ejection fraction (\<50%)
* Non-reversible airway obstruction (post-bronchodilator FEV1/FVC \< 0.7 and FEV1 \< 80 %)
* Respiratory muscle weakness (Pi,max \< 70cmH2O)
* Persistent dyspnea on daily life (Baseline Dyspnea Index focal score \<or= 8).

Exclusion Criteria:

* Inability to perform exercise tests
* Diagnosed psychiatric or cognitive disorders
* Progressive neurological or neuromuscular disorders having a major impact on exercise capacity
Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Multiple Myeloma (MYELOMEFRAGIQUANTI)

Multiple myeloma is a disease that causes increased bone fragility which is often revealed or complicated by vertebral fractures. Invasion of bone marrow by tumor plasma cells leads to bone destruction and reduced fat fraction. The main objective is to assess the correlation between vertebral bone marrow fat fraction and bone fragility represented by a severity score of vertebral fractures. The secondary objective is to assess the correlation with clinical and biological prognostic factors and scores..

Patients treated with vertebroplasty will be included during the period of the study, retrospectively or prospectively.

Mains collected data are represented by :

* Bone marrow fat fraction determined by MRI
* Severity score for vertebral fractures
* Clinical prognostic factors
* Biological prognostic factors
* Clinico-biological scores Descriptive statistics and correlation analyses will be performed between the measured parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients followed for multiple myelomas in the Lariboisière/Saint-Louis/Fernand-Widal hospital group
* vertebral fractures treated by vertebroplasty from January 2017 to December 2021
* recent clinical and biological data available at the time of imaging and fracture events

Exclusion Criteria:

* Factors modifying the bone marrow fat fraction (extensive radiotherapy)
* Lack of recent clinical or biological data compared to imaging examinations
Vascular and Neuro-inflammatory Effects of Endurance Exercise Training in African Americans

The purpose of this study is to test the effects of endurance exercise training on arterial structure and function, and to examine potential mechanisms producing changes in arterial structure and function in young (18-35 years of age) African Americans when compared to Caucasians.

African-Americans are at greater risk than Caucasians for developing hypertension, cardiovascular disease, stroke and renal disease. This is likely related to arterial dysfunction including greater arterial stiffness, and reduced microvascular reactivity of resistance arteries in African-Americans. In addition, African-Americans have higher levels of inflammatory markers, and a greater sympathoexcitatory response to various stressors. This imbalance between sympathetic and reduced parasympathetic activation may directly affect vascular function and potentiate a greater inflammatory response, further altering key structural and functional properties of the vascular wall. The overall aim of this proposal is to test the effects of endurance exercise training on arterial structure and function, and to examine potential mechanisms producing changes in arterial structure and function in young (18-35 years of age) African Americans when compared to Caucasians. We will examine these effects at rest and following a high intensity (maximal cycle ergometry) sympathoexcitation at both pre- and post-intervention time points, since sympathoexcitation may elucidate changes not evident at rest. Because African-Americans have higher levels of arterial stiffness, lower microvascular reactivity, greater responses to sympathoexcitation, greater levels of inflammatory markers and greater vasoconstrictive tone, we hypothesize that African-Americans will show differential responses to exercise training and benefit more compared to a matched group of Caucasians.

Eligibility Criteria:
Inclusion Criteria:

* Subjects in good health with no cardiovascular, metabolic, or inflammatory disease, who do not use cardiovascular medications or antioxidant vitamin supplementation, including use of anti-inflammatory (including aspirin) or steroidal substances in the past 2 months will be inlcuded

Exclusion Criteria:

* Subjects who smoke, are severely obese (body mass index \> 35 kg/m2), or who have hypertension (blood pressure \>140/90mmHg), diabetes (fasting glucose \>110mg/dl), hyperlipidemia, inflammatory disease (rheumatoid arthritis and systemic lupus erythematosus, etc) or diagnosed cardiovascular disease including, coronary heart disease, hypertension and cardiac arrhythmia or renal disease, will be excluded
Combination Therapy Effect of Laser on Wound Healing and Bone Regeneration of Dental Sockets

The goal of this clinical trial is to learn if the laser works to improve wound healing and bone regeneration after tooth extraction. The main question it aims to answer is:

Does laser therapy improve wound healing and bone regeneration after tooth extraction?

Researchers will compare a laser to sham laser therapy to see if the laser enhances wound healing and bone regeneration.

Participants will:

Have exposure to laser or sham laser therapy immediately after tooth extraction Record their pain intensity on days 2, 4, 6 and 14 Visit the clinic after 10 days for follow-up Again, visit the clinic after 4 months for evaluation


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years old, regardless of gender
* Non-traumatic tooth extraction of the lower jaw is indicated
* Willing for dental implant surgery
* Dental appointments are available at the study place
* Absence of active infection at the extraction site
* Signed informed permission is provided.

Exclusion Criteria:

* Pregnant, lactating, and menopausal women
* Smokers
* Those having head and neck radiotherapy
* Those with any sort of acute infection (e.g., periodontal abscess), immune deficiency, or metabolic conditions such as diabetes mellitus and osteoporosis
* Patients will also be eliminated if they have a complication during surgery, such as bleeding or operational difficulties, or if the procedure takes longer than 90 minutes.
Behavioral Therapy Of Obstetric Sphincter Tears

The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12 and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks postpartum, subjects will be contacted by telephone for evaluation of FI symptoms. Symptoms of FI will be defined by at least monthly symptoms of leakage of liquid, solid stool, and mucus. Flatal incontinence will be assessed at 24 weeks, based on the Fecal Incontinence Severity Index, and fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire. A sample size of approximately 400-450 subjects will be enrolled.

The primary aim of the "BOOST Cohort Study" is to determine the incidence of FI symptoms at 6 and 12 weeks postpartum in primiparous women sustaining an OASI.

Secondary aims of the cohort study are:

1. To determine the incidence rates of FI symptoms at 24 weeks post delivery in primiparous women sustaining an OASI
2. To examine the relationship between the modified WHO sphincter tear classification types and FI symptoms
3. To examine predictors (socio-demographic, physical and clinical) associated with WHO sphincter tear classifications (3a, 3b and 4) and predictors associated with FI symptoms
4. To evaluate the incidence of fecal urgency and flatal incontinence at 24 weeks postpartum in primiparous women sustaining an OASI.

Eligibility Criteria:
Inclusion Criteria Assessed by 2 weeks postpartum

1. Vaginal delivery \>= 28 weeks singleton gestation
2. Documented repair to the anal sphincter at delivery
3. First vaginal delivery
4. Ambulatory
5. Able to give informed consent 6 Adult women \>= 18 years of age

Inclusion Criteria at 2 weeks postpartum

1. Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease)
2. Pre-pregnancy ano-rectal surgery (e.g., surgery for hemorrhoids, fissures, sphincterotomy)
3. Pre-pregnancy FI (defined as the leakage of liquid/solid stool and mucus \>= once per month for at least 12 weeks prior to this pregnancy)
4. Neurological condition that would predispose to FI (e.g., spinal cord injury, multiple sclerosis)
5. Presence of rectovaginal fistula
6. Any participation in other pharmacologic or behavioral studies for FI
7. Previous pregnancy \>=28 weeks delivered vaginally or by Cesarean section
Restylane Defyne Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds

This is a randomized, split face, multicenter study to evaluate the efficacy and safety of Restylane Defyne compared to Restylane in correction of NLFs.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Men or women aged 18 years of age or older of Chinese origin.
3. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study.
4. Intent to undergo correction of both NLFs with a wrinkle severity in WSRS of either 3 on both sides or 4 on both sides, as assessed by the blinded evaluator.

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) Gel and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics.
2. Previous tissue revitalization treatment below the level of the lower orbital rim within 6 months before treatment.
3. Previous surgery or tattoo in the area to be treated.
4. Previous tissue augmentation therapy or contouring with any permanent (nonbiodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat or permanent implant below the level of the lower orbital rim.
5. Previous use of neurotoxins or any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment.
6. Scars or deformities, active skin disease, inflammation or related conditions such as infection, perioral dermatitis, seborrheic dermatitis, eczema, rosacea, acne, psoriasis, and herpes zoster near or in the area to be treated.
7. Other condition preventing the subject from entering the study in the Investigator's opinion
18432-Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.