cyrilzakka/clinical-trials huggingface dataset:
The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester

Early preterm premature rupture of membranes (PPROM) complicates 0.7% of pregnancies. When PPROM occurs before the 24th week,the risk of fetal and neonatal death is 70%. There is also a high risk of neonatal and maternal morbidity. When the diagnosis of PPROM is uncertain by physical examination, additional tests are needed. These tests have false positive and false negative rates. The gold standard for diagnosing PPROM is amniocentesis and dye test. This procedure has a risk of infection and abortion.Our hypothesis is that by using a cervical cap for 6 hours and repeated ultrasound exams we can diagnose or rule out PPROM in cases which are uncertain. Our study group will be pregnant women gestational age 14-23, suspected of having PPROM.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age 14-23
* Single fetus
* Suspected rupture of membranes
* Oligohydramnios

Exclusion Criteria:

* Vaginal bleeding
* Suspected chorioamnionitis
The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals

This study collected real-world evidence to better understand and define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels).


Eligibility Criteria:
Inclusion Criteria:

* Receive AgelessRx's standard Rapamycin treatment protocol
* Opted to complete at least 1 blood draw at their local Quest Lab

Exclusion Criteria:

* Not approved for current AgelessRx standard Rapamycin treatment
* History of uncontrolled disease
* Unable to complete at least 1 blood draw at their local Quest Lab
Continuous Wound Infiltration After Hallux Valgus Surgery

The aim of this study is to investigate the effect of continuous wound infiltration with ropivacaine in comparison to standard pain management after elective distal metatarsal osteotomy for postoperative pain control.

The aim of this study is to investigate the effect of continuous wound infiltration with ropivacaine in comparison to standard pain management after elective distal metatarsal osteotomy for postoperative pain control. The primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (NRS; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. The secondary outcome parameters included postoperative rescue opioid consumption, clinical outcome (AOFAS forefoot score, ROM of MTP joint of the greater toe), incidence of postoperative complications, and patient satisfaction with surgery on a numeric rating scale (1-10).

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing a distal metatarsal osteotomy (only Chevron or Scarf) and lateral release of the adductor halluces muscle with/without concomitant osteotomy of the proximal phalanx of the greater toe (Akin) for idiopathic hallux valgus deformity will be included.

Exclusion Criteria:

* hallux valgus surgery other then mentioned above or concomitant other procedures
* denial to participate and give informed consent
* patients with neurological diseases that affect the sensory-motor function
* patients with any short-term (1 month) previous surgery on affected lower extremity
* allergies or other comorbidity that prohibits standardized pain regime (renal insufficiency, severe heart or liver impairment, uncontrolled asthma, history of peptic ulcera )
* patients unwilling to undergo surgery without general anesthesia
Repetitive Nerve Stimulation to Improve Recovery After Stroke

Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral sensory stimulation (RPSS) is a novel strategy to improve upper limb motor performance in the post-stroke chronic phase but its effects in the subacute phase are still poorly understood. The objectives of this study are to compare the effects of RPSS on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke confirmed by computed tomography or magnetic resonance imaging, between 7 days - 3 months before enrollment (subacute phase), and at least 6 months (chronic phase).
* Ability to perform at least 4 of 7 tasks performed in daily life that is part of the Jebsen-Taylor Test

Exclusion Criteria:

* Anesthesia of the paretic hand.
* Lesions affecting the motor cortex (hand area).
* Lesions affecting cerebellum, or cerebellar pathways in the brainstem.
* Severe spasticity at the paretic elbow, fist or fingers, defined with a score larger than 3 on the Modified Ashworth Scale.
* Neurological diseases such as Parkinson disease or chronic uncontrolled chronic disease such as cancer or cardiac insufficiency.
* Elbow pain or join deformity in the paretic limb.
* Pregnancy.
* Uncontrolled psychiatric disease.
* Aphasia or severe cognitive deficit.
* Inability to provide consent.
* Inability to attend the experimental sessions.
Research and Development of Novel Quantitative Magnetic Resonance Imaging (MRI) Techniques in a Single Scan for Multiple Organ Application

Cross-sectional observational study to improve MRI data acquisition techniques by optimising MRI sequences for multiple organs and assessing the repeatability and reproducibility of multiparametric MRI, in healthy volunteers.

This will be a cross-sectional, observational study recruiting up to 200 healthy participants designed at improving MRI data acquisition techniques by optimising MRI sequences and assessing different aspects of the repeatability and reproducibility of multiparametric MRI. Participants will be recruited from Perspectum's own networks, as well as through advertisements on social media platforms (e.g. Facebook, Instagram), Perspectum's website, as well as through charities.

Suitable participants will be invited to attend a screening visit, normally over the telephone, which will involve collection of participant's self-reported medical evaluation to assess eligibility according to the inclusion and exclusion criteria.Visit 1 will consist of the collection of basic anthropometric measurements (e.g. height, weight, waist circumference), a medical history, and a MRI scan. Visit 2 will be a repeat of Visit 1.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Any contraindication to magnetic resonance imaging (incl. pregnancy, nonremovable electronic implants including cochlear implants, infusion pumps, and pacemakers, shrapnel injury, severe claustrophobia, allergic reaction to contrast agents)
* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study
Clinical Outcomes of Transvaginal Mesh Procedures for Cystocele Repair: Comparisons of Uphold and Perigee Systems

Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women.

The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.

Pelvic organ prolapse (POP) is a major health concern, affecting more than 30% of women. Traditional vaginal surgery with native tissue is associated with high recurrence rate. Thus, synthetic meshes were introduced into POP surgery and became the mainstream. Several transvaginal mesh procedures, such as Uphold system (Boston Scientific) and Perigee system (American Medical Systems Inc), have been used for cystocele repair. Perigee system is a trans-obturator four-arm mesh device attached to proximal and distal arcus tendineus fasciae pelvis. Nonetheless, Uphold system, is a single incised, two-arm anterior sacrospinous mesh fixation system. Both systems can be used for cystocele repair, despite Uphold system can be used for concomitant repair of apical prolapse. The aim of this study was to compare the clinical outcomes of Uphold system and Perigee system in treating women with cystocele.

Eligibility Criteria:
Inclusion Criteria:

1. Vaginal anterior wall prolapse greater than or equal to second phase of POP-Q
2. Underwent Uphold or Perigee procedures

Exclusion Criteria:

* nil
Study of a Pandemic Influenza Vaccine

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next avian influenza pandemic. This study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* History of Guillain-Barre syndrome or active neurological disease
Chlorhexidine Gluconate Versus Saline for Flushing the Surgical Area During Colorectal Cancer Surgery

The aim of this study was to compare the effectiveness of chlorhexidine versus saline in flushing the surgical area during colorectal cancer surgery. The primary outcomes included surgical site infection, postoperative complication rates, et al.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-85 years,
2. Patients with surgically resectable colorectal tumors confirmed by CT/MRI before surgery
3. All patients had a performance status score of 0 or 1 in the Eastern Tumor Cooperative group
4. American Society of Anesthesiology grade I-III

Exclusion Criteria:

1. The tumor may have distant metastasis
2. History of previous abdominal surgery
3. The patient has a history of other malignant tumors diagnosed in the past 5 years and has received radiotherapy and chemotherapy in the past
4. There are obvious contraindications to surgery (obvious abnormal liver and kidney function, pregnancy)
5. Participated in other clinical trials within the past 6 months
Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior

The purpose of this study is to determine whether a sensor device called an Automatic Ingestion Monitor (AIM) that is worn on eyeglasses can be used with a smartphone to change eating behavior. Participants will wear the device for one week of no-intervention observation. They will then test behavioral interventions focused on eating for two weeks. The researchers hypothesize that messages sent to a smartphone that are based on information from the AIM can reduce the amount of food that is eaten and slow eating.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 27 and 45 kg/m-squared
* Weight stable within 5% in the past 6 months
* Self-reports basic familiarity with use of a smartphone

Exclusion Criteria:

* Diagnosed diabetes (type 1 and 2)
* Any poorly controlled medical condition that could affect weight and/or eating behavior (e.g., hypothyroidism)
* Medical conditions or use of medications or diets/supplements known to affect energy regulation or appetite
* Difficulty chewing or swallowing
* Diagnosed eating disorder
* Night or shift work
* Current participation in a weight loss program
* History of bariatric surgery
* Current pregnancy or lactation within the past 1 year, or planning a pregnancy during the study participation period
* Consuming a medically-prescribed or unusual diet (e.g., macrobiotic)
* Food allergies or sensitivities, or other conditions which result in avoidance of a wide range of foods (e.g. celiac disease, tree nut allergy)
* Reported recreational drug use
* Report of conditions that would significantly interfere with an ability to follow the protocol including terminal illness, substance abuse, or other significant uncontrolled psychiatric problem
Evaluation of rhGH Replacement Therapy in Patients With Pseudohypoparathyroidism Type Ia (PHP Ia)

We have recently demonstrated resistance to GHRH leading to GH deficiency in patients with Pseudohypoparathyroidism type Ia (Mantovani et al., J Clin Endocrinol Metab, 2003. 88: 4070-4074). The purpose of this study is to evaluate the effect of at least 1-year GH replacement in these patients. In particular, we will focus our attention on growth velocity in children affected with this disease.

Albright's Hereditary Osteodystrophy is a rare autosomal dominant disease characterized by a constellation of physical features including short stature, central obesity, round face, brachydactyly, subcutaneous calcifications and mental retardation. In the same family, it may present associated to end organ resistance to the action of different hormones, primarily PTH, TSH and gonadotropins and in this case it is named PHP type Ia, or on the contrary we may find it as an isolated defect and this is the case of PPHP.

In about 80% of affected families, heterozygous loss of function mutations in the Gs alpha gene are detected. It is of interest mutations inherited from the mother always lead to the complete form of the disorder, that is PHP; on the contrary when the same mutations are inherited from the father, patients show the physical abnormalities of Albright's Osteodystrophy, without any evidence of hormone resistance. This pattern of inheritance is consistent with a tissue-specific paternal imprinting of the Gs alpha gene. Imprinting is an epigenetic phenomenon by which one of the 2 alleles undergoes partial or total loss of expression; in the case of the Gs alpha gene one would expect that only the paternal allele should be lost in specific endocrine tissues, such as the kidney, the thyroid and the gonad, which are the target organs resistant to hormone action in PHP Ia. Indeed, our group demonstrated that in specific human endocrine tissues also Gs alpha transcription mainly derives from the maternal allele (Mantovani et al., J Clin Endocrinol Metab, 2002. 87: 4736-4740). In particular a predominant maternal origin of transcription was found in thyroid and gonad and these data are consistent with the clinical finding of TSH and gonadotropin resistance present in patients affected with PHP. Interestingly, we observed a predominance of the maternal allele also in the pituitary gland, an organ which is not classically included among the target organs resistant to hormone action in PHP Ia.

Following this observation, we have recently demonstrated resistance to GHRH leading to GH deficiency in most of our patients with PHP Ia (Mantovani et al., J Clin Endocrinol Metab, 2003. 88: 4070-4074). The purpose of this study is to evaluate the effect of at least 1-year GH replacement in these patients. In particular, we will focus our attention on growth velocity in children affected with this disease.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and/or genetic diagnosis of Pseudohypoparathyroidism type Ia
* Growth hormone deficiency

Exclusion Criteria:

* Known malignancies
Ultrasound-Guided Versus Anatomically Guided Botulinum Toxin Injection in Spasticity in Adults in Tanta University Hospitals

This study aimed to compare the safety and outcome of ultrasound (US)- guided botulinum toxin (BoNT) injection and anatomically guided injection in muscle spasticity of different causes in adults.

One of the major complications of neurological diseases is spasticity which is defined as an increased velocity-dependent muscle tone.

A large volume of clinical data has demonstrated the efficacy and safety of botulinum toxin type A (BoNT-A) products for treating conditions such as spasticity.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Both sexes.
* Patients with muscle spasticity.

Exclusion Criteria:

- Patients with contraindications to botulinum toxin injection as allergy, myasthenia gravis, and cerebral palsy.
Effects of Exercise Training and AGE-crosslink Breaker on Cardiovascular Structure and Function

Healthy but sedentary aging leads to increased morbidity and mortality of cardiovascular disease. This is partly due to the accumulation of Advanced Glycation Endproducts (AGEs) and the stiffening of the myocardium and arteries. New medication has been developed to break these AGE-crosslinks to improve cardiovascular compliance. The positive influence of regular physical activity is well known for cardiovascular disease and aging. Therefore, what is the most effective intervention, physical exercise and/or new medication AGE-crosslink breakers, in improving the cardiovascular and cerebrovascular compliance and improving the endothelial function in healthy sedentary elderly.


Eligibility Criteria:
Inclusion Criteria:

* Healthy sedentary elderly
* Age 65 yrs and older

Exclusion Criteria:

* Cardiovascular disease
* Cerebrovascular disease
* Changes on ECG indicating cardiomyopathy or ischemia
* No cardiovascular medication
* Diabetes Mellitus
* Hypercholesterolemia
* BMI \> 33 kg/m2
* Intensive exercise \> 1 hour a week
Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes

A study is to see if methyldopa can change the immune system's attack on insulin producing cells in people at early stages of type 1 diabetes.

The study is a randomized, double blinded, placebo-controlled, multi-center crossover clinical trial.

Eligible subjects will be randomized in a 1:1 allocation ratio to one of two treatment schedules: first methyldopa then placebo vs. first placebo then methyldopa.

The study objective is to assess the safety, efficacy, and mode of action of methyldopa to reduce DQ8 antigen presentation in individuals at Stage 1 and 2 of type 1 diabetes (T1D).

Eligibility Criteria:
Inclusion Criteria:

* Participant in TrialNet Pathway to Prevention Study (TN01)
* Willing to provide Informed Consent or, if the subject is \<18 years of age, have a parent or legal guardian provide Informed Consent
* Confirmed positive for one or more autoantibodies, one of which is insulin autoantibody (mIAA)
* Positive for at least one gene encoding HLA-DQ8 (DQB\*0302)
* If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and during the study
* Have normal or abnormal glucose tolerance on OGTT performed within 7 weeks of randomization

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent or comply with study protocol
* History of clinically significant anemia or Hemoglobin \<10 g/dl
* Evidence of liver dysfunction
* History of renal insufficiency
* History of symptomatic hypotension including positional hypotension
* Systolic BP \< 100 mmHg for adults or blood pressure \< 5th percentile for age/height/gender in children and adolescents
* Use of a treatment that is known to cause a significant, ongoing change in the course of diabetes or immunologic status, within 4 weeks prior to participation. This includes high-dose inhaled, extensive topical or systemic glucocorticoids
* Females who are pregnant at the time of screening, breastfeeding or unwilling to defer pregnancy during the 16-month study period. (Female participant must be at least 100 days postpartum before enrollment into study)
* Unable to avoid concurrent antihypertensive medications, monoamine oxidase (MAO) inhibitors, lithium, or medications containing ferrous sulfate or ferrous gluconate
* Unable to avoid medications that affect stomach pH, such as proton pump inhibitors or histamine H2 receptor blockers
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study

This is a single-arm, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in Chinese patients with ES-SCLC in the real world. Patients with ES-SCLC who already use or plan to use Trilaciclib will be invited to participate in the study. Data were collected from 28 days prior to initial chemotherapy (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed consent until patients died, dropped out of the study, lost to follow-up, informed withdrawal, or study termination. The end time of the study was defined as withdrawal of information, loss of follow-up or death of all enrolled patients, or 12 months after the last patient was enrolled, whichever happened earlier.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate and sign informed consent;
2. must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender:
3. Patients with extensive small-cell lung cancer confirmed by histology or cytology
4. Patients suitable for Trilaciclib combined with platinum/etoposide or Trilaciclib combined with topotecan treatment

Exclusion Criteria:

1. Patient is currently participating in other Interventional clinical studies;
2. Patients received systemic chemotherapy other than the regimens recommended in inclusion criteria 4 During Trilaciclib treatment.
PET/CT: Role in Detecting Unknown Primary Head and Neck Cancer

Historically metastatic squamous cell carcinoma in a cervical lymph node from an occult primary malignancy of the head and neck was evaluated with panendoscopy and biopsies of high risk areas, such as the base of tongue, nasopharynx, and tonsils. This diagnostic protocol identifies the primary malignancy in about 50% of cases. In recent years, the availability of CT has slightly increased the detection rate to 65% when used as an adjunct to the traditional work-up. Studies using PET as an adjunct are conflicting with detection rates ranging up to 75%. Currently, no prospective study has analyzed the role of the PET-CT fusion in the work-up of an occult primary malignancy of the head and neck. This study will compare the detection rate of the traditional work-up to a new protocol involving a pre-operative diagnostic PET-CT.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Biopsy proven SCC in a cervical lymph node
* Unknown primary cancer after: History, Physical exam, and office endoscopy by otolaryngologist
* Negative Chest X-Ray for malignancy
* Patient consent signed to undergo investigative protocol

Exclusion Criteria:

* Un-fit for general anesthesia
* Unable to lie flat for 45 minutes
* Unable to fast for \> 6 hours
* Unable to perform PET-CT (Obesity \> 150kg)
* Pregnant
* Prior Head and Neck cancer
* Any invasive cancer (Non-Head and Neck) within the last 2 years