cyrilzakka/clinical-trials huggingface dataset:
Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy

The study objective is to evaluate the effectiveness of oral tramadol 50 mg in reducing pain during the colposcopy-directed cervical biopsy.half of the patients will receive oral tramadol tablets and the other half will receive a placebo.

.Colposcopy-directed cervical biopsy (CDB) is a procedure performed in women with abnormal Papanicolaou smear or abnormal human papillomavirus (HPV) testing whose cervical lesions are colposcopically identified. Generally, no anaesthesia is needed for the procedure which can be done on an outpatient basis.The degree of pain associated with this procedure varies from mild to severe and many studies suggested that pain levels are often high reaching a score of more than 40 points on a 100-point visual analogue scale (VAS). Tramadol hydrochloride is an orally active centrally acting synthetic opioid. It is an atypical analgesic with a dual mechanism of action: serotonin and norepinephrine reuptake inhibition and modest l-opioid agonist. It has a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents

Eligibility Criteria:
Inclusion Criteria:

Women with abnormal cervical cytology candidate for colposcopy and colposcopically directed biopsy or loop electrosurgical excision procedure.

Exclusion Criteria:

* Patients taking psychotropic or anticoagulant medications or with histories of bleeding disorders or bleeding ulcers.
* Cervical and vaginal infection
* pregnant patients.
* Patients who had taken analgesics in the previous 24 hours, had a history of drug abuse or allergy to tramadol or opioids
* Patients with contraindications to tramadol as severe asthma, severe renal or hepatic impairment, People with uncontrolled epilepsy.
* People under the influence of (intoxicated with) alcohol, sleeping tablets, tranquilisers, psychotropic drugs (those affecting mood or emotions) or other opioid painkillers, e.g. morphine, codeine.
Treating the Resistant Patent Ductus Arteriosus (PDA)

Persistent postnatal ductal patency may have significant adverse hemodynamic effects, frequently necessitating therapeutic intervention in order to facilitate ductal closure. Medical therapy for patency of the ductus arteriosus is successful mediating ductal closure in approximately 70% of treated infants. In a recent study in our population, 17% of the babies showed no ductal response to the first course of treatment and 9.4% of our study infants eventually underwent surgical ligation of the ductus after failure of medical therapeutic closure.We propose to evaluate and compare two alternate therapeutic approaches to ductal closure in babies who do not respond to initial therapy.


Eligibility Criteria:
Inclusion Criteria:

* Inborn premature neonates admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and diagnosed as having a hemodynamically significant patent ductus arteriosus (sPDA) will be considered as potential candidates for study if/when they do not respond to initial therapy

Exclusion Criteria:

* Any baby not considered viable
* Any baby with IVH grade 3-4 of recent onset (within 3 days. \[If no head ultrasound has been performed within the last 3-4 days, one should performed prior to onset of study.\]
* Any baby with dysmorphic features or congenital abnormalities
* Any baby with structural heart disease other than PDA
* Any baby with documented infection,
* Any baby with thrombocytopenia (\<50,000).
Connectome Characterization With Aging

The main aim of this project is to develop a new model to characterize brain connectivity and its changes with aging. This characterization will be based on new sensitive and specific markers, allowing a better understanding of structural and functional brain networks. To this end, two complementary MRI methods will be developed: 1) Resting-state functional MRI (rs-fMRI) which allows the measurement of cerebral activity in different cortical gray matter regions, and 2) high angular resolution diffusion imaging (HARDI) MRI, which allows to characterize brain tissue microarchitecture. HARDI sequences will be developed to acquire and reconstruct fiber tractography of patient's brains. In combination with conventional MRI, both HARDI and rs-fMRI will be used to estimate the connection degree between each pair of cortical regions, so- called "Connectome". Once generated, brain networks will be quantified through numerous graph metrics, such as graph density, global efficiency and assortativity (etc.), reflecting the organization and topology of subjects' connectivity with aging.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers (Men and women) aged between 18 and 50 years
* No neurological or psychiatric diseases

Exclusion Criteria:

* MRI contraindications
* Pregnant women or nursing women
* Persons under guardianship or any other administrative or deprivation of liberty or of right
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002899)

Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in male and female subjects with hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18 to 65 years old, inclusive
* Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.
* Have no clinically significant disease or abnormal laboratory results taken at the screening visit.

Exclusion Criteria:

* Known sensitivity to DMEM/F-12 or any component of the study material.
* Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
* Subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.
* A history of drug or alcohol abuse within 1 year of study enrollment.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Any clinically significant abnormal laboratory parameters.
* A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
* Dermatologic condition in donation and/or study areas.
* Prior surgery in the treatment area.
* Insufficient hair or scarring in the donor area that might impact cell growth.
* Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
Minocycline Accelerates Intracerebral Hemorrhage Absorption

Minocycline has been found to reduce cerebral edema secondary to cerebral hemorrhage, promote hematoma absorption, and shorten hematoma absorption time; clinical studies have been conducted to confirm the safety in the treatment, but no significant hematoma absorption effect was seen with short duration of drug use. Therefore, the investigators propose to conduct a multicenter randomized controlled clinical trial to determine its accelerating effect on hematoma absorption.

There is a significant increase in the incidence of spontaneous intracerebral hemorrhage, combined with a high mortality rate. Surgical treatment is mainly used to remove intracerebral hematoma with a supratentorial volume greater than 20ml, and most intracerebral hematomas below 20mL are left to absorb on their own, and the absorption time of such hematomas is about 4 to 6 weeks. Minocycline is a tetracycline antibiotic routinely used in clinical practice for the treatment of bacterial infection and acne.

It has been found that it can not only reduce iron overload after intracerebral hemorrhage and inhibit neuroinflammation, but also reduce secondary cerebral edema. Some animal experiments have confirmed that it can promote hematoma absorption through iron chelation and shorten hematoma absorption time; clinical studies have been conducted to confirm the safety in the treatment of intracerebral hemorrhage, but no significant effect has been seen with short duration of drug use. No clinical RCT study has been conducted to confirm its accelerating effect on the absorption of adult intracerebral hematoma. Therefore, the investigators propose to conduct a multicenter randomized controlled clinical trial to determine its accelerating effect on hematoma absorption, and this study will have important clinical practical value.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Spontaneous intracerebral hemorrhage by CT scan
* Intracerebral hematoma volume is less than 16ml
* No surgical treatment of hematoma evacuation

Exclusion Criteria:

* Allergies to tetracycline antibiotics
* Pregnancy or suspected pregnancy (pregnancy test will be done on women with fertility potential)
* Hepatic and/or renal insufficiency
* Glasgow Coma Scale of 5 or less
* Secondary cerebral hemorrhage caused by trauma, arteriovenous malformation, aneurysm, tumor or other reasons
* Thrombocytopenia (platelet count\<75000/mm3) or coagulation dysfunction (INR\>1.4)
* Incapable to take care of themselves in past life (score of Rankin scale before stroke\>2)
* Signed DNR (Do Not Resuscitate)
Effect of Nitroglycerin Hydrogel on Repairing Critical Bone Defects

Due to their osteoconductive, osteoinductive, and osteogenic qualities, autologous bone grafts are the gold standard for augmenting bone, (1). However, problems, insufficient bone quantity, and/ or quality at the donor location could prevent it from being used. Consequently, a variety of bone graft materials, such as allografts and/or xenografts, were developed to improve bone development and provide an osteoconductive matrix in the so-called hard tissue critical-size defect (CSD) (2).

"critically-sized" defect is regarded as one that would not heal spontaneously despite surgical stabilization and requires further surgical intervention (3). The management of critical-sized bone defects remains a major clinical orthopedic challenge. Critical-sized bone defects are technically defined as those that will not heal spontaneously during the patient's lifetime. Bone loss greater than 2 times the diameter of the long bone diaphysis is unlikely to result in union despite appropriate stabilization methods (4).

Nitroglycerin, also known as glyceryl trinitrate (GTN), is a medication commonly used to treat heart conditions like angina pectoris and chronic heart failure. It acts as a potent vasodilator, dilating the vascular system to improve blood flow. Nitroglycerin has been found to have a positive effect on bone formation. Studies indicate that Nitroglycerin when applied topically, can increase bone formation and reduce bone resorption. This effect is achieved through the stimulation of osteoblastic differentiation and proliferation (5).

The mechanism of action of Nitroglycerin in bone formation involves its conversion into nitric oxide (NO), which plays a crucial role in stimulating bone formation. Nitric oxide released from nitroglycerin acts as a signaling molecule that enhances osteoblastic differentiation and proliferation of bone marrow-derived mesenchymal stem cells. This process leads to increased bone mineral density, improved bone geometry, and enhanced bone strength (5).

Hydrogels are natural or synthetic biocompatible polymers that are widely used in periodontal tissue engineering as a delivery material for different biologics (6). Synthetic hydrogels have superiority in chemical and mechanical properties over natural hydrogels (7). Carbopol or polyacrylic acid (PAA) is one of the most widely used polymers as a hydrogel. It is an anionic polyelectrolyte that can be readily polymerized and crosslinked to form hydrogels with a swelling capacity greater than their dry weight (8).

Aim of the study Histomorphometric analysis of Regenerative Capacity of Nitroglycerin-loaded hydrogel in management of critical size bone defect in Experimental study.

Materials and Methods

Eligibility Criteria:
Inclusion Criteria:

* All animals were adult with an age ranging between 3 to 7 months and a weight ranging between 250 and 350 g

Exclusion Criteria:

* other than inclusion
Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial

To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding.

Acute uterine bleeding, unrelated to pregnancy, is a relatively common problem that causes many reproductive-aged women to requite emergent medical and/or surgical intervention. Although the traditional approaches have generally been surgical in nature, many practitioners utilize medical methods to arrest the bleeding. However, despite widespread use, there exists a paucity of information regarding the effectiveness, side-effects, and patient satisfaction associated with the commonly-used medical regimens. (b) The purpose of the study is to compare the efficacy of multidose medroxyprogesterone acetate and a multidose, monophasic combined oral contraceptive in the treatment of hemodvnamically-stable women with non-gestational, acute uterine bleeding.

(c) Non-pregnant, hemodynamically-stable, reproductive-aged, women, over the age of IS, who present either to the emergency area or to KP practitioner's offices with acute uterine bleeding, will be considered for eligibility. If, following a full exam and medically appropriate investigations medical management is deemed appropriate, they will be approached by a member of the investigating team for possible inclusion into the study. Following informed consent, patients will be randomized to receive either medroxyprogesterone acetate (20 mg three times daily for 7 days) or monophasic oral contraceptive containing I mg of norethindrone and 35 ug of ethinyl estradiol (three dines daily for seven days). Following the seven days of therapy, those randomized to MPA will continue with 20 mg per day for three weeks while those randomized to oral contraceptives will take one pill per day for three weeks, each completing a total of four weeks of therapy. The primary outcome will be the number of days until cessation of bleeding. Other outcomes measured will include pad and tampon counts, and hemoglobin levels. Chi square tests and student t will be used to evaluate differences between the two treatment groups. The hope is that this study will elucidate on the efficacy of the two regimens.

Eligibility Criteria:
Inclusion Criteria:

Non-pregnant Hemodynamically stable Reproductive-aged women \>18 years Present with acute uterine bleeding

Exclusion Criteria:

Pregnant Non-hemodynamically stable \<18 years
Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia

Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis

This is a single institution phase 2 clinical trial evaluating the efficacy, safety, and tolerability of tailored temozolomide therapy for patients with acute myeloid leukemia (AML) and poor risk features.

Patients will be assigned to 1 of 2 parallel treatment groups based on their AGAT promoter region methylation status, as determined by PCR.

Patients achieving a complete remission after 1 to 2 cycles of chemotherapy will be eligible to receive up to an additional 5 cycles of temozolomide of 5 or 19 days, depending on the methylation status of the AGAT promoter (consolidation phase).

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed Acute Myeloid Leukemia, as defined by the WHO classification.
2. Patients must be considered unfit for conventional induction chemotherapy, unwilling to receive such treatment or have evidence of disease relapse or refractory disease.
3. For patients who have received no prior conventional chemotherapy, one of the following must be present:

   * Poor risk cytogenetics (complex abnormalities, deletions of chromosome 7 or 5, 11q23 abnormalities, inv\[3\])
   * Secondary leukemia (prior hematologic disorder or therapy-related leukemia).
4. Age \> 60 years of age.
5. Life expectancy of greater than 3 months.
6. ECOG performance status greater than 2.
7. Patients must have normal organ and marrow function as defined below:
8. Adequate hepatic function: Total bilirubin 1.5mg/dL, AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal.
9. Adequate renal function: serum creatinine within normal institutional limits or Calculated creatinine clearance \> 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
10. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
2. Patients may not be receiving any other investigational agents.
3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or DTIC
4. History of gastrointestinal disease or significant bowel resection that could interfere with drug absorption.
5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
6. Prior allogeneic stem cell transplantation.
7. Inability to swallow tablets
8. Prior radiation up to more than 25% of bone marrow.
MRI & QST Analysis in Trigeminal Neuralgia and Persistent Idiopathic Facial Pain

Patients with a definite diagnosis of classical TGN and PIFP will undergo a structured clinical questionnaire and a trigeminal sensory profile using the quantitative sensory testing. Clinical measures and sensory profiles will be correlated with MRI measures.

Patients with a definite diagnosis of classical TGN and PIFP (according to the 2020 ICOP Classification) will undergo a structured clinical questionnaire and a trigeminal sensory profile using the quantitative sensory testing. Clinical measures and sensory profiles will be correlated with the presence and the geometry of neurovascular compression at MRI. Moreover quantitative structural neuroimaging analysis, such as trigeminal root volume, will be performed in each patient and correlated with clinical and QST data.

Eligibility Criteria:
Inclusion Criteria:

* Definite diagnosis of Classical or Idiopathic Trigeminal Neuralgia or Persistent Idiopathic Facial Pain according to the latest ICOP 2020 Criteria
* Naive to any surgical procedures

Exclusion Criteria:

* Any major chronic painful or other neurological disease
* Diagnosis of Secondary Trigeminal Neuralgia
* Diagnosis of other facial pain syndromes
* Cognitive disturbances
Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods

This is a randomized controlled trial which is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.

Secondary intention is an established method of allowing post-surgical defects to heal. Previous studies have shown a positive association between the frequency of debridement and healing rates in chronic wounds. However, the effect of debridement on acute, post-surgical wounds is not well-described in the literature.

This randomized controlled trial is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.

Eligibility Criteria:
Inclusion Criteria:

1. Dermatology patients at Lahey Clinic:
2. who have undergone Mohs surgery or excision
3. who are older than 18 years
4. who are able to give consent
5. who had postoperative defects allowed to heal by secondary intention on the a) head and neck, b) trunk and upper extremities, c) lower extremities
6. who are willing and able to return to clinic in Peabody, MA, for all wound care visits

Exclusion Criteria:

1. Unable to consent (due to language barrier or mental status)
2. Unable to perform daily wound care
3. Unwilling or unable to return for follow-up
4. Have baseline venous stasis or pitting edema of the affected limb
5. Wear compression stockings or require use of a compressive bandage (such as an Unna Boot) at baseline.
Variability of Sulfotransferase 1A1 Activity in Humans: an Approach to Improve Predictive Drug Response - Part I: Analysis of Intraindividual Variation in Healthy Adults

An open-label, single centre, nonrandomized clinical study in healthy volunteers, with intervention over a 13---week period. After written informed consent, subjects will undergo screening evaluations (Visit 1). One week after visit 1, subjects who meet the selection criteria will enter a run---in period of 8 weeks where participants will receive paracetamol 1g tablet and collect a blood sample at monthly intervals (visits 2, 3 and 4). A final visit for safety assessment will take place at week 13 (visit 5). Blood samples will be used to quantify P, PG e PS.

To be able to predict efficacy and adverse reactions involving compounds metabolized by sulfonation, the investigators need more information on SULTs. Studies of in vivo sulfonation in humans are lacking, although they are of key importance in assessing the functional consequences of individual variation. In our current study, the investigators will start by developing an HPLC method of quantifying SULT1A1 activity using paracetamol as probe substrate and studying intraindividual variation in healthy adults. Advantages of using paracetamol as a probe substrate for in vivo phenotyping of SULT1A1 include: wide safety margin for in vivo use, easy and ready administration of the drug, significant metabolism by the enzyme of interest, short half---life, linear pharmacokinetics over a wide concentration range and a limited number of metabolites, quantifiable in plasma.15,24 In a subsequent study, the investigators plan to study interindividual variation in a larger sample, including subjects with chronic disease and on medication.The investigators expect to provide a valuable new tool to explore the clinical significance of variation of SULT1A1 activity, the most important SULT on drug metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, over 18 years of age,
* Informed of the nature of the study and giving written informed consent,
* Report no significant diseases during screening,
* Have normal CBC, renal function and liver enzymology,
* Have no contraindication for paracetamol,
* Be on no regular medical treatment, except for contraceptives,
* Be able to communicate effectively with study personnel.

Exclusion Criteria:

* Hypersensitivity or idiosyncratic reaction to paracetamol,
* Intake of any medication, except for contraceptives, within 14 days before start of the study,
* Pregnancy or breastfeeding,
* BMI \<18 kg/m2,
* Participation in a clinical study of any investigational product 1 month prior to visit 1 or during the study.