cyrilzakka/clinical-trials huggingface dataset:
Pelvic Tilt Following Puerperium

The slight anterior pelvic tilt is a physiological posture in healthy males and females, however, excessive anterior pelvic tilt is associated with different lumbopelvic discomfort either during gestation or after childbirth.

As pregnant women move from the 1st to the 3rd trimester, they exhibit a notable increase in the angle of pelvic tilting. This may explain the painful pelvic girdle syndrome during gestation which can last for several weeks postpartum.

When women finish their 6 weeks of puerperium, it may be suspected to return in the pelvic tilting angle to its measurements prior to gestation.

Eligibility Criteria:
Inclusion Criteria:

* Women who underwent cesarean delivery
* Women who were classified as having normal or overweight score on body mass index
* Women in their 6-12 weeks postpartum

Exclusion Criteria:

* Women who underwent vaginal delivery
* Women who were obese on the body mass index
* Women with postpartum duration of less than 6 weeks or more than 12 weeks
Development of a Couple-based Mindfulness Intervention for Chronic Pain

Chronic pain is a costly public health problem that is associated with poor quality of life. Previous research has demonstrated extensive evidence showing that pain coping is not manifested by patients in isolation but within the context of significant relationships such as marriage. For instance, a partner may avoid or reject their partners' negative emotions about pain, provide unempathic responses to their partners' pain, or change their thoughts about pain. The patient's pain experience and the couples' relationship also have a cyclical relationship, in which both can affect each other and the overall quality of life for both partners. Currently, current clinical practice does not target both partners to alleviate pain. This is highly problematic given that a number of chronic pain patients-those with interpersonal distress-often do not complete, and thus, do not benefit fully from existing treatments. Even if treatment is completed, individuals may not maintain improvements if they return to distressed social environments that undermine individual coping efforts. Thus, it is clear that new interventions derived from integrative models of individual and dyadic coping are needed to alleviate pain and suffering in patients who are at risk for poor treatment outcomes. This research study aims to develop a novel psychological intervention aimed at couples in which one partner has chronic pain. Our central hypothesis is that a theoretically integrative intervention that improves both partners' psychological flexibility (i.e., acceptance, mindfulness, values-based action) and relational flexibility (i.e., emotional disclosure, empathic responding) skills will be feasible and valid and that it will alleviate pain and improve quality of life. This is a departure from current practice, which focuses solely on the patient's individual functioning, does not address the spouse's psychological inflexibility, and does not address relationship issues.


Eligibility Criteria:
Inclusion Criteria:

* At least one spouse with some pain interference.
* Relationship dissatisfaction.
* Both partners at least 21 years old.
* Couples must also be married or cohabitating for at least 2 years regardless of sexual orientation to participate in the study.

Exclusion Criteria:

* Current suicidal or homicidal ideation or intent
* Current psychotic symptoms
* Cognitive impairment
* Malignancies (e.g., cancer) in either partner
* Current domestic violence
Clonidine and Morphine in Caudal Anesthesia

Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.

It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.

Eligibility Criteria:
Inclusion Criteria:

* Urogenital pediatric surgery
* Status physical(ASA) 1 and 2

Exclusion Criteria:

* Cutaneous infection in puncture site
The CROCO Study: CROhn's Disease COhort Study

The investigators propose to create a prospective Crohn Disease cohort, where patients receiving the most up-to-date therapies with a treat-to-target strategy, will be closely followed to characterize the progression of Crohn Disease by measuring the Lémann Index over time. The goal of the CROCO Study - "Crohn's Disease Cohort Study" is to promote a greater understanding of the long-term evolution of Crohn Disease , to describe prospectively the impact of different therapeutic strategies and develop accurate predictors of bowel disease damage and disability.

Therefore, the investigators designed a prospective, multicentre, study of the clinical course, anatomical progression and treatment of newly diagnosed CD and plan to include 600 patients over a 2-year period. Patients will be followed over 5 years after diagnosis (the date of diagnosis will be the date of the index histopathology describing CD; in special situations where pathology is not available the date of diagnosis will be the date that CD was declared by the physician). A morphological evaluation (LI), using abdominal magnetic resonance, will be performed at 1, 3 and 5 years after diagnosis. Ileocolonoscopy, upper endoscopy and/or pelvic MRI will be included according to disease location. Patients will be treated with standard of care therapy and will be followed for 5 years after diagnosis, with semestrial visits after the Year 1 (LI 1). At each visit, clinical and laboratory markers will be collected. Perianal and abdominal surgeries during follow-up will be registered. The disability index questionnaire will also be recorded every year.

A preliminary requisite is therefore to implement and standardize examination reports and damage definitions used to calculate the LI. To this end, training session, supervised by members of the steering committee, will be held for participating gastroenterologist and radiologists. Based on commented ileocolonoscopy, upper endoscopy abdominal MRI and pelvic MRI, these sessions will highlight how lesions should be characterized and graded accordingly to implement the Lémann Index.

Eligibility Criteria:
INCLUSION CRITERIA

To be eligible all of the following criteria must be met:

* Diagnosis of CD (according to ECCO guidelines) established within the past 12 months;
* Patients able to understand the information provided to them and to give written informed consent for the study;
* Male or female, age \> 18 years.

EXCLUSION CRITERIA:

* Patients unwilling or unable to provide informed, written consent;
* Severe underlying medical disorder with an anticipated life expectancy \< 2 years;
* Refusal or medical conditions (e.g. Glomerular filtration rate \< 30 mL/min) preventing cross-sectional imaging during follow-up;
* Uncertain CD diagnosis;
* Pregnancy (if it is impossible to implement the MRE at one year) or any other reason that makes resonance not feasible throughout the study (eg claustrophobia).
Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People

This type of study can have an impact on public health policy and help improve the management of pain in people with EHPAD; Propose better use of drug treatments and non-pharmacological methods such as osteopathy; Help structuring the healthcare sector.

* "Osteopathy" group: 3 osteopathy sessions of 45 min with one session every 3 weeks at S2, S5 and S8. Fascial osteopathic techniques performed will consist of gentle and non-impulsive manipulation
* "Simulated" group: 3 simulated osteopathy sessions lasting 45 minutes, one session every 3 weeks at S2, S5 and S8. The techniques performed will consist of an application of the hands to different anatomical regions than the group "osteopathy" without therapeutic intention, that is to say without tissue tensioning.

The pain will be assessed at inclusion (S0) and at the end of the procedure (S12) by the head physician, the coordinating physician or the psychomotor therapist, ignoring the assignment group of the subject and before each session. osteopathy (at S2, S5 and S8) by a nurse or psychomotor also ignoring the patient's assignment group.

Both groups will continue to benefit from their usual allopathic management and recommendations.

Patients will not be aware of the treatment received (osteopathy or simulated) and will be randomized by a computer server.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 75 years
* Patients Residing in Accommodation Facilities for Dependent Old People
* A score measured by the DOLOPLUS 2 Scale at least 7/30 at the start of the study
* For patients in capacity and autonomous: Patients informed and having signed a free and informed consent.

For non-capable patients with a trusted person and / or guardian: Informed patients whose confidant or guardian has been informed and has signed free and informed consent.

- Affiliated to a social security scheme (beneficiary or beneficiary)

Exclusion Criteria:

* Absence of pain
* Medical contraindication known to the practice of osteopathy with fascial aim (advanced degenerative bone disease, metastatic cancer)
* Osteopathic treatment in the last six months
* Patients under curators
A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer

This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and preliminary efficacy of HP568 alone and in combination with palbociclib in patients with ER+/HER2- locally advanced or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-75 years old (inclusive of both ends) at the time of signing the informed consent form.
2. Patients with locally advanced inoperable or recurrent or metastatic breast cancer ER+/HER2- advanced breast cancer is confirmed by histopathology have confirmed that the primary and/or metastatic lesion.
3. Previously received at least 1-line endocrine therapy (endocrine therapy duration ≥ 6 months) and ≤ 2-line chemotherapy (≤ 2-line chemotherapy limited to dose escalation stage) for the recurrence or metastasis stage of the disease. The third stage : Inclusion of patients who have not received prior treatment but are suitable for CDK4/6i therapy.
4. Disease progression confirmed by imaging occurs during or after the last systemic anti-tumor treatment before the first medication.

Exclusion Criteria:

1. Known or suspected allergy to any ingredient of HP568 formulation, and allergy to any ingredient of palbociclib (only applicable to stage III).
2. Within 42 days prior to the first administration, Fluvistran was used; Other endocrine therapies such as tamoxifen, toremifene, letrozole, anastrozole, and exemestane were used within 14 days prior to the first administration.
3. Previously received other ER-ROTAC drugs such as ARV-471.
4. Within 6 weeks before the first administration of HP568 in this study, nitrosoureas or mitomycin were used; Received any anti-tumor treatment, including immunotherapy, chemotherapy, radiotherapy, or targeted therapy, within 28 days prior to the first administration (or of the drug's 5 half lives,take the shorter one).
Latanoprost for the Treatment of Menière's Disease

The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Definitive unilateral Menière's disease (AAO-HNS 1995)
* Disease stage II - III: PTA4 (Pure Tone Average) (0.5, 1.0, 2.0 and 3.0kHz) between 25dB and 70dB
* Speech discrimination score in silence: No better than 85%
* At least three vertigo attacks (lasting ≥ 20 minutes) during the last three months prior to inclusion
* Tinnitus during the last three months prior to inclusion
* Signed written informed consent

Exclusion Criteria:

* Medical or psychiatric conditions which could jeopardize or would compromise the subject's ability to participate in the trial or decrease the likelihood of obtaining satisfactory data to achieve the objective of the trial, dementia, alcohol or substance abuse.
* Bilateral Menière's disease
* Chronic otitis media on the ear affected by Menière's disease
* Subjects not fluent in Swedish language
* Bronchial asthma
* Previous intratympanic injection of gentamicin or surgical therapy
* Previous intratympanic steroid therapy less than six months prior to inclusion
* Known hypersensitivity to local anesthetics
* Pregnant women
* Nursing mothers
Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography

This Minimal Risk study is designed to evaluate the ability of the Celero ingestible Vitals Monitoring Pill (i.e., VM Pill) to measure respiration from within the gastrointestinal tract, in addition to performing an exploratory comparative analysis of data collected by the VM Pill and data collected from clinical monitoring sensors as part of polysomnography.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals ages 18 - 65 inclusive who are indicated for a polysomnography study.

Exclusion Criteria:

* Patients with a history of abdominal surgery and/or any condition that may impact the GI tract, including but not limited to:

  * Constipation
  * Esophageal stricture
  * Esophagitis
  * Gastritis
  * Gastric ulcers
  * Peptic ulcer
  * Gallstones
  * Celiac Disease
  * Crohn's Disease
  * Ulcerative Colitis
  * Irritable Bowel Syndrome
  * Diverticulitis
  * Colorectal cancer
Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors

In adrenal tumors, the investigators will examine if there is any correlation between WIESS criteria, prognosis of the tumor, and the different labeling index of the following proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN, SEMAPHORIN-3A.

One of the problems in managing adrenocortical tumors is the ability to distinguish between benign and malignant tumors, while needle biopsy is unable to distinguish between the two situations. Therefore, when imaging tests demonstrate a suspected malignant adrenal tumor, surgical excision of the tumor is needed. Usually, the histological WIESS criteria are used in order to determine malignancy. However, there are cases when adrenal tumors were defined by WIESS criteria as benign but metastasized later. Moreover, there is no reliable test than can determine prognosis. KI-67 labeling index is a proliferation biomarker which is used to tell more about the malignant potential and prognosis of adrenal carcinoma.

In various types of tumors, proliferation biomarkers are used in attempt to tell about prognosis. In this study, the investigators will examine whether some biomarkers can differentiate between adrenal carcinoma and adenoma and if the degree of expression of these markers is correlated with prognosis.

The investigators will retrospectively collect 30 cases of adrenal carcinoma, 30 cases of adrenal adenoma and 10 cases of normal adrenals. All specimens are preserved with formalin. The investigators will re-review the WIESS criteria and all samples will be analyzed for the index labeling of the following proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN, SEMAPHORIN-3A. The investigators will examine if there is any correlation between the labeling index of each biomarker, WIESS criteria and prognosis of the tumor.

Eligibility Criteria:
Inclusion Criteria:

* adrenal carcinoma
* adrenal adenoma
* normal adrenal tissue

Exclusion Criteria:

* NA
Effect of TPN171H on Spermatogenesis

This study is a phaseⅠstudy to determine the acute effects of TPN171H on semen function in healthy male subjects.

Safety Study in male subjects

Eligibility Criteria:
Inclusion Criteria:

1. Male aged 18\~40years (included)
2. Body Mass Index of 19 to 28 kg/m2; Body weight no less than 50 kg;
3. Sperm concentration ≥15\*10\^6/ml, Sperm motility(a+b(%))≥32%, Semen volume ≥1.5 ml, Liquefaction time≤60 min
4. Sperm sample should be collected after a minimum of 2 days and a maximum of 7 days of sexual abstinence.
5. Take reliable contraceptive measures
6. Physical examination, vital signs examination, laboratory examination, ECG were normal or abnormal without clinical significance;
7. Be able to understand and willing to sign the Informed Consent Form;

Exclusion Criteria:

1. People with azoospermia, teratozoospermia, moderate-to-severe asthenozoospermia, and moderate-to-severe oligozoospermia and other abnormal semen disease
2. People with vasectomy and ligation
3. People who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H;
4. There are clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
5. Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
6. A history of fainting needles or fainting blood;
7. Blood loss or blood donation of 400 mL or more within 3 months before administration;
8. Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration
9. those who have participated in other drug clinical trials and received trial drugs within 3 months before
10. Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine);
11. Urine drug screening positive；
12. Smoking more than 10 cigarettes per day ；
13. Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
14. he investigator believes that there are other factors that are not suitable for participating in this trial.
Assessment of Adductor Canal Blockade in Anterior Cruciate Ligament Surgery

Assessment of sensory and motor blockade of adductor canal blockade performed for anterior cruciate ligament repair in comparison with femoral nerve blockade.

The adductor canal blockade is a reliable technique for analgesia after knee surgery. It is a safe technique, avoiding muscle weakness, and by this way limiting the risk of fall. Injection of local anaesthetics in the adductor canal does not block the sole saphenous nerve. Demonstration of a proximal spreading, around the branches of the femoral nerve have been made. The aim of this study is to assess a possible spreading from the adductor to the the popliteal fossa, where sciatic nerve and its branches are located. Pinprick test all around the knee and the leg, combined with motor assessment of the muscle of the leg and the ankle will be realised. This assessment was compared with femoral nerve blockade, classically used for analgesia after this kind of surgery (anterior cruciate ligament repair)

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for anterior cruciate ligament repair

Exclusion Criteria:

* Refusal to study,
* coagulation disorder,
* infection at the puncture site,
* preexisting neuropathy,
* allergy to local anesthetics,
* renal or hepatocellular insufficiency,
* context of chronic pain,
* drugs abuse,
* pregnant patient
Phase 1 Study of XAF5 Gel Applied to Skin of Healthy Volunteers

This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when applied to the skin of healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Must understand and provide informed consent
* Skin upon which a reaction would be visible
* Body weight \>= 70 kg

Exclusion Criteria:

* Any active skin disease
* History of skin hypersensitivity
* Clinically significant abnormality on physical exam, ECG, or laboratory tests
* Positive test for HIV, Hepatitis B, or Hepatitis C
To Investigate Blood Lipid Changes and Safety After Litorvazet® Tablets in Dyslipidemia Patients

This study aims to investigate the lipid-lowering effects and safety of administering Litorvazet tablets (ezetimibe/atorvastatin) over a 24-week period in patients with dyslipidemia scheduled to receive Litorvazet tablets in a real-world clinical setting.

In a real-world clinical setting, Litorvazet® tablets will be administered to patients based on the investigator's medical judgment in accordance with the approved prescribing information (indications, dosage, and administration, precautions for use, etc.).

Participants for data collection in this study will be patients diagnosed with dyslipidemia as determined by the judgment of their attending physician.

All treatments, including drug administration and clinical laboratory tests conducted after the administration of Litorvazet® tablets, will be carried out based solely on the investigator's (attending physician's) medical judgment and will not be influenced by the patient's participation in the study. Information relevant to this observational study will be collected for up to 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults aged 19 years or older at the time of the screening visit.
* Patients with dyslipidemia who are scheduled to receive Litorvazet® tablets based on the investigator's (treating physician's) medical judgment and in accordance with the approved indications.
* Individuals who have voluntarily provided written consent to participate in this study.

Exclusion Criteria:

* Individuals who meet any contraindications for Litorvazet® tablets as specified in the product labeling:
* Those with hypersensitivity to any components of this medication.
* Patients with active liver disease or those with persistently elevated serum transaminase levels of unknown cause.
* Patients with muscle disorders.
* Pregnant women, women who may be pregnant, or breastfeeding mothers.
* Women of childbearing potential who are not using appropriate contraceptive methods.
* Patients receiving glecaprevir and pibrentasvir.
* Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
* Individuals with a history of receiving Litorvazett® tablets prior to participating in this study.
* Individuals deemed unsuitable for participation in this observational study by the investigator (treating physician) for reasons beyond those listed above.